Body Cream at night.
Amazon.com: L'Occitane - Shea Butter - Body Lotion: Beauty Your Store Beauty See All 32 Product Categories Your Account | Cart | Wish List | Help | Browse Brands & Products | Free Gifts & Special Offers | Fragrance | Makeup | Skin Care | Bath & Shower | Hair Care | Men's Grooming Search Amazon.com Beauty Skin Care Makeup Fragrance Bath & Shower Hair Care Men's Grooming Health/Personal Care Web Search This item is not eligible for Amazon Prime, but over a million other items are. Join Amazon Prime today. Already a member? Sign in . or Sign in to turn on 1-Click ordering. A9.com users save 1.57% on Amazon. Learn how . See larger image Share your own customer images L'Occitane - Shea Butter - Body Lotion Other products by L'Occitane More about this product Price: $30.00 Availability: Usually ships in 1-2 business days. Ships from and sold by L'OCCITANE . Product Promotions Get free shipping on your order when you purchase $80.00 or more from L'OCCITANE. Here's how (restrictions apply) Product Description Product Description Daily moisture solution for dry skin, in a non-breakable squeeze bottle ideal for shower and travel. Introduces your body to a trove of nature's treasures, including 15% Shea Butter (derived directly from the African Shea tree), natural honey, and apricot oil. Nourishes, moisturizes and protects: keys to maintaining the look of health. Lifts the senses with subtle essences of jasmine and ylang-ylang. Important Information Directions Smooth onto body after showering or bathing, or any time skin feels "hot," dry or tight. Perfect for shower or travel; cherished as a smoothing, clean-scented essential by both women and men. In cold months, or when skin is especially dry or flaky, use Shea Butter Body Lotion in the morning and Shea Butter Ultra Rich Body Cream at night. Product Details Product Dimensions: 8.5 ounces Shipping Information: View shipping rates and policies Note: Gift-wrapping is not available for this item. ASIN: B0002F01TS Amazon.com Sales Rank: #3,111 in Beauty (See Top Sellers in Beauty ) Yesterday: #2,237 in Beauty This page was created by a seller. Customers who bought this item also bought L'Occitane - Shea Butter - Hand Cream L'Occitane - Shea Butter - Extra Gentle Milk Soap L'Occitane - Shea Butter - Extra Gentle Milk Soap Molton Brown Re-Charge Black Pepper Body Wash Explore Similar Items Customer Reviews Be the first person to review this item . So You'd Like to... Make Moving To A New Home A Breeze? : A guide by Livin' The Good Life , Anticipating our move... Revive the Art of the Bath : A guide by S.D.Northwest , Bath Connoisseur be like Ray Charles : A guide by cherylt19102 , A guide by Cheryl Tanaka a Ray Charles the man fa... 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Category: Aftershave, Volume: 50ml, Gender: ForMen, Occasion: Daytime, Launch Date: 1994 ... Antonio Puig Aqua Quorum (50ml) AftershaveFull Specs Category: Perfume & Aftershave Brand: Antonio Puig Category: Aftershave Gender: For Men Compare Prices Product Information Similar Products Search : Product Shop Condition Price Total Price More Antonio Puig Aqua Quorum Aftershave 50ml Free UK delivery on all orders! Aqua Quorum by Antonio Puig 50ml Aftershave - Price ?7.99 Men`s Fragrance No further details for this product.. This is a genuine item, not a tester. Store info Reviews in progress (Less than 10 reviews) New 7.99 + P & P: Free 7.99 Puig Aqua Quorum 50ml After Shave 50ml Puig introduced Aqua Quorum in 1994. This fine fragrance contains amber, freesia, lavender and is accented with oakmoss, geranium and grapefruit. Aqua Quorum is recommended for daytime use. Store info Write a review! New 8.59 + P & P: Free 8.59 Puig Aqua Quorum 50ml After Shave 50ml Puig introduced Aqua Quorum in 1994. This fine fragrance contains amber, freesia, lavender and is accented with oakmoss, geranium and grapefruit. Aqua Quorum is recommended for daytime use. Store info Write a review! New 8.59 + P & P: Free 8.59 Antonio Puig Aqua Quorum Aftershave Spray 50ml Antonio Puig launched its Aqua Quorum scent in 1994. It is a refreshing, spicy, lavender, amber fragrance that possesses a blend of herbal top notes and lower notes of leather. Aqua Quorum also contains freesia, and is accented with oak moss, geranium and grapefruit. It is recommended for daytime... Store info Read 11 Reviews New 7.04 + P & P: 0.95 7.99 Delivery costs provided by individual stores. All prices, including free delivery, are to UK mainland addresses with some exceptions. Please check store terms and conditions before making your purchase. 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Shopping guides Kelkoo Toolbar Shopping in Europe: Denmark / Sweden / Belgium (FR) / Belgium (NL) / France / Germany / Italy / Netherlands / Norway / Spain Generated : 27-01-2006 05:21:37 Hand Care Kits Amazon.comAmazon.com Crabtree & Evelyn Store: Hand Care / Hand Care Kits Your Store Beauty See All 32 Product Categories Your Account | Cart | Wish List | Help | Shop by Fragrance | Shop by Product | Personal Care | Home Fragrance | Shop for Gifts | Accessories Search Hand Care Kits Amazon.com Crabtree & Evelyn Beauty Web Search Expand Your Results Any Category in Crabtree & Evelyn, not just Hand Care Kits Narrow by Brand Crabtree & Evelyn (4) Narrow by Price $25-$49 (4) Listmania! 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Search Amazon.com Books Popular Music Music Downloads Classical Music DVD VHS Apparel Yellow Pages Movie Showtimes Toys Baby Computers Video Games Electronics Camera & Photo Software Tools & Hardware Office Products Magazines Sports & Outdoors Outdoor Living Kitchen Jewelry & Watches Beauty Gourmet Food Musical Instruments Health/Personal Care Pet Supplies Travel Cell Phones & Service Outlet Auctions zShops Everything Else Automotive for Amazon.com Home | Directory of All Stores Our International Sites: Canada | United Kingdom | Germany | Japan | France | China Help | Shopping Cart | Your Account | Sell Items | 1-Click Settings Investor Relations | Press Room | Careers Conditions of Use | Privacy Notice © 1996-2006, Amazon.com, Inc. or its affiliates Acne Cream (Benzoyl PeroxideEnforcement Report for September 8, 2004 FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA Enforcement Report The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities. September 8, 2004 04-36 RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II _______________________________ PRODUCT Assorted Old Fashioned Candies; 16 pieces per box; 7.6 oz. Recall # F-426-4. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Dulzura Borincana, Moca, PR, by store visit beginning on April 21, 2004. Firm initiated recall is complete. REASON The product contains undeclared colors - FD&C Yellow # 5, FD&C Yellow #6, and Red # 40. VOLUME OF PRODUCT IN COMMERCE 24 cases/12 bowls/16 pieces. DISTRIBUTION PR. _______________________________ PRODUCT John Frieda brand Sheer Blonde Curvaceous Blonde Curl-Defining Styler, Curls Swirls Brightens Blond Hair, packaged in 6.7 fl. Oz. plastic bottles with pump sprayer, 6 bottles per case. Item/SKU #7-17226-00502-2; Order No. 0723859. Recall # F-427-4. CODE Lots: # S001AW037 and #S001AW040. RECALLING FIRM/MANUFACTURER Andrew Jergens Co, Cincinnati, OH, by email, fax, and letter on March 22, 2004. Firm initiated recall is complete. REASON The product may be contaminated with Burkholderia cepacia. VOLUME OF PRODUCT IN COMMERCE 104 cases. DISTRIBUTION PA. RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III _______________________________ PRODUCT Guava filled cakes (Panetela de Guayaba), packaged in plastic bags of 12 pieces and plastic container of 24 pieces. Recall # F-428-4. CODE All product on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Carlas Sweets, Bayamon, PR, by visit beginning on April 12, 2004. Firm initiated recall is ongoing. REASON Product contains undeclared color additive, FD&C Red # 40. VOLUME OF PRODUCT IN COMMERCE 8,928 units. DISTRIBUTION Local supermarkets, chain stores, and department stores. RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II _______________________________ PRODUCT a) 5% Benzoyl Peroxide Gel packaged in 1-oz. tubes, 12 per case, OTC, under the following private labels: Schnucks; 2) Harris Teeter; and 3) Finast. Recall # D-266-4; b) Invisible Acne Cream (Benzoyl Peroxide 10%), 1-oz. tubes, 12 per case, OTC, under the following private labels: 1) Western Family Maximum Strength Invisible Acne Cream; 2) Meijer Invisible Acne Cream Maximum Strength, 3) Stop & Shop Maximum Strength Invisible Acne Cream; 4) Best Yet Absolute Elements Maximum Strength Invisible Acne Cream; 5) Premier Value Maximum Strength Invisible Acne Cream; 6) Finast Maximum Strength Invisible Acne Cream; 7) Personal Expressions Vanishing Acne Cream; 8) HyVee Maximum Strength Invisible Acne Cream. Recall # D-267-4. CODE a) Lot #3J21D and 3L18D; b) Lot #3J16B, Exp. Oct 2005; 3J16C, Exp. Oct 2005; 3J16D, Exp. Oct 2005; 3K18B, Exp. Nov 2005; 4A22B, Exp. Jan 2006; 4A22C, Exp. Jan 2006; 4A28A, Exp. Jan 2006; 4B12B, Exp. Feb 2006; 4B25C, Exp. Feb 2006; 4C03C, Exp. Mar 2006; 4D03A, Exp. Apr 2006; and 4D07A, Exp. Apr 2006. RECALLING FIRM/MANUFACTURER Quailis, Inc., Des Moines, IA, by letter on July 16, 2004 and July 22, 2004. Firm initiated recall is ongoing. REASON Bacterial contamination. VOLUME OF PRODUCT IN COMMERCE 48,588 tubes. DISTRIBUTION Nationwide. RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III _______________________________ PRODUCT Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) 0.45 mg/1.5 mg tablets, Rx only, 1 EZ-DIAL Dispenser of 28 tablets, NDC #0046-0937-09. Recall # D-268-4. CODE A46796, Exp. March 2005. RECALLING FIRM/MANUFACTURER Richmond Division of Wyeth, Richmond, VA, by letters dated August 12, 2004. Firm initiated recall is ongoing. REASON Dissolution Failure. VOLUME OF PRODUCT IN COMMERCE 24,871 units. DISTRIBUTION Nationwide. RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II _______________________________ PRODUCT a) Whole Blood. Recall # B-1531-4; b) Red Blood Cells. Recall # B-1532-4; c) Red Blood Cells, Leukocytes Reduced. Recall # B-1533-4; d) Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-1534-4; e) Platelets. Recall # B-1535-4; f) Platelets, Irradiated. Recall # B-1536-4; g) Fresh Frozen Plasma. Recall # B-1537-4; h) Cryoprecipitated AHF. Recall # B-1538-4. CODE a) Unit numbers: 24FC19939, 24FC19981, 24FC20405, 24FC20850, 24FC21029, 24FC21033, 24FC21035, 24FC21053, 24FC21438, 24FC21442, 24FC21456, 24FC21473; b) Unit numbers: 24FC18821, 24FC18878, 24FC18973, 24FC18974, 24FC18978, 24FC18989, 24FC19023, 24FC19039, 24FC19278, 24FC19309, 24FC19315, 24FC19380, 24FC19925, 24FC19959, 24FC19975, 24FC20016, 24FC20817, 24FC20826, 24FC20839, 24FC21037, 24FC21184, 24FC21199, 24FC21206, 24FC21301, 24FC21440, 24FC21466 c) Unit numbers: 24FC18818, 24FC18822, 24FC18824, 24FC18826, 24FC18829, 24FC18848, 24FC18852, 24FC1885 24FC18860, 24FC18864, 24FC18865, 24FC18901, 24FC18920, 24FC18923, 24FC18925, 24FC18931, 24FC18963, 24FC18972, 24FC18982, 24FC18995, 24FC18998, 24FC19005, 24FC19010, 24FC19012, 24FC19013, 24FC19289, 24FC19290, 24FC19293, 24FC19295, 24FC19296, 24FC19297, 24FC19299, 24FC19313, 24FC19314, 24FC19326, 24FC19327, 24FC19328, 24FC19330, 24FC19390, 24FC19392, 24FC19393, 24FC19394, 24FC19409, 24FC19412, 24FC19414, 24FC19930, 24FC19961, 24FC19972, 24FC19992, 24FC19993, 24FC20001, 24FC20012, 24FC20013, 24FC20014, 24FC20023, 24FC20024, 24FC20026, 24FC20028, 24FC20037, 24FC20042, 24FC20043, 24FC20044, 24FC20048, 24FC20050, 24FC20054, 24FC20067, 24FC20068, 24FC20069, 24FC20074, 24FC20075, 24FC20090, 24FC20092, 24FC20094, 24FC20096, 24FC20358, 24FC20360, 24FC20377, 24FC20378, 24FC20386, 24FC20388, 24FC20520, 24FC20539, 24FC20540, 24FC20544, 24FC20700, 24FC20735, 24FC20987, 24FC20988, 24FC21002, 24FC21003, 24FC21116, 24FC21131, 24FC21132, 24FC21133, 24FC21135, 24FC21147, 24FC21149, 24FC21183, 24FC21185, 24FC21196, 24FC21292, 24FC21300, 24FC21312, 24FC21313, 24FC21317, 24FC21322, 24FC21324, 24FC21325, 24FC21458, 24FC21474, 24FC21484, 24FC20565, 24FC20572, 24FC20574, 24FC20577, 24FC20584, 24FC20820, 24FC20829, 24FC20830, 24FC20833, 24FC20834, 24FC20837, 24FC20848, 24FC20859, 24FC20860, 24FC20861, 24KG56510, 24KG58159, 24KG58162, 24KG58163, 24KG58175, 24KG58176, 24KH95846, 24KH95847, 24KH95848, 24KH95851, 24KH95871, 24KH95875, 24KH95877, 24KH95878, 24KH95881, 24KH95882, 24KH96472, 24KJ69126, 24KJ69127, 24KJ69129, 24KJ69142, 24KJ69143, 24KJ69146, 24KJ70003, 24KJ70004, 24KJ70050, 24KJ70051, 24KJ70052, 24KJ70054, 24KJ70058, 24KJ70073, 24KJ70078, 24KJ70090, 24KJ70091, 24KJ70092, 24KJ70093, 24KJ70106, 24KJ70108, 24KJ70113, 24KJ70114, 24KJ70128, 24KJ70129, 24KJ70130, 24KJ70140, 24KJ70316, 24KJ70320, 24KJ70325, 24KJ70339, 24KJ70340, 24KJ70341, 24KJ70343, 24KJ70346, 24KJ70349, 24KJ70351, 24KJ70353, 24KM83399, 24KM83400, 24KM83406, 24KM83411, 24KM83414, 24KM83467, 24KM83469, 24KM83474, 24KM83475, 24KQ56116, 24KQ56117, 24KQ56132, 24KQ56133, 24KQ56142, 24KQ56146, 24KR21873, 24KR21874, 24KR21880, 24KR21881, 24KR21882, 24KR21884, 24KR21885, 24KR21890, 24KR21891, 24KR21892, 24KR21895, 24KR21896, 24KR21900, 24KR21902, 24KS56066, 24KS56067, 24KS56068, 24KS56071, 24KS56074, 24KS56075, 24KS56077, 24KS56078, 24KS56081 24FC18636, 24FC19021, 24FC19022, 24FC19040, 24FC19041, 24FC19051, 24FC19053, 24FC19259, 24FC19260, 24FC19261, 24FC19270, 24FC19272, 24FC19273, 24FC19345, 24FC19347, 24FC19356, 24FC19358, 24FC19360, 24FC19379, 24FC19381, 24FC19385, 24FC19731, 24FC19751, 24FC19752, 24FC19758, 24FC19767, 24FC19768, 24FC19776, 24FC19778, 24FC19779, 24FC19913, 24FC19924, 24FC19937, 24FC19944, 24FC19945, 24FC19947, 24FC19948, 24FC19956, 24FC19962, 24FC19963, 24FC20097, 24FC20149, 24FC20151, 24FC20153, 24FC20631, 24FC20635, 24FC20657, 24FC20659, 24FC20670, 24FC20672, 24FC20674, 24FC20677, 24FC20682, 24FC21021, 24FC21026, 24FC21051, 24FC21056, 24FC21057, 24KC33488, 24KC33489, 24KC33490, 24KC33492, 24KC33495, 24KC33504, 24KC33505, 24KH93842, 24KH93844, 24KH93846, 24KH93849, 24KH93851, 24KH93859, 24KH94851, 24KH94852, 24KH94853, 24KH94854, 24KH94861, 24KH95010, 24KH95450, 24KH95451, 24KH95453, 24KH95459, 24KH95467, 24KH95492, 24KH95494, 24KH95498, 24KH96442, 24KH96444, 24KJ70008, 24KJ70016, 24KJ70019, 24KJ70020, 24KJ70032, 24KJ70033, 24KJ70034, 24KJ70039, 24KJ70040, 24KJ70043, 24KJ70046, 24KJ70049, 24KL65170, 24KL65171, 24KL65173, 24KL65184, 24KL65185, 24KM83145, 24KM83148, 24KM83154, 24KM83160, 24KM83163, 24KM83164, 24KM83172, 24KQ56162, 24KQ56482, 24KQ56501; d) Unit numbers: 24FC20566, 24FC20573, 24FC19036, 24FC19037, 24FC20099, 24FC20630, 24FC20632, 24KC33486, 24KH95009, 24FC18912, 24FC18928, 24FC18983, 24FC19312, 24FC19966, 24FC20000, 24FC20045, 24FC20401, 24FC20714, 24FC21004, 24FC21118, 24FC21120, 24FC21146, 24FC21210, 24FC21461, 24FC21475; e) Unit numbers: 24FC19021, 24FC19036, 24FC19037, 24FC19050, 24FC19051, 24FC19345, 24FC19347, 24FC19379, 24FC19385, 24FC19731, 24FC19767, 24FC19768, 24FC19776, 24FC19778, 24FC19913, 24FC19924, 24FC19937, 24FC19944, 24FC19945, 24FC19947, 24FC19956, 24FC19962, 24FC20632, 24FC20657, 24FC20659, 24FC20670, 24FC20672, 24FC20674, 24FC20677, 24FC20682, 24FC21026, 24FC21051, 24FC21052, 24FC21057, 24KC33486, 24KC33489, 24KC33505, 24KH93846, 24KH93849, 24KH93851, 24KH93859, 24KH94851, 24KH94852, 24KH94861, 24KH95451, 24KH95453, 24KH95467, 24KH95494, 24KH95498, 24KH96442, 24KJ70016, 24KJ70020, 24KJ70032, 24KJ70033, 24KJ70034, 24KJ70039, 24KJ70040, 24KJ70046, 24KL65170, 24KL65173, 24KL65184, 24KL65185, 24KM83148, 24KM83154, 24KM83160, 24KM83163, 24KM83164, 24KQ56162, 24KQ56499, 24KQ56501; f) Unit numbers: 24FC19948, 24FC19963, 24KC33488, 24KC33490, 24KC33492, 24KH93842, 24KH93844, 24KH95010, 24KM83145; g) Unit numbers: 24FC19021, 24FC19024, 24FC19036, 24FC19037, 24FC19041, 24FC19050, 24FC19051, 24FC19053, 24FC19345, 24FC19347, 24FC19356, 24FC19358, 24FC19359, 24FC19360, 24FC19379, 24FC19381, 24FC19385, 24FC19731, 24FC19752, 24FC19758, 24FC19776, 24FC19778, 24FC19779, 24FC19913, 24FC19924, 24FC19937, 24FC19944, 24FC19945, 24FC19947, 24FC19948, 24FC19956, 24FC19962, 24FC19963, 24FC20151, 24FC20153, 24FC20572, 24FC20630, 24FC20632, 24FC20635, 24FC20657, 24FC20659, 24FC20670, 24FC20672, 24FC20674, 24FC20677, 24FC20682, 24FC20833, 24FC20834, 24FC20848, 24FC20859, 24FC20860, 24FC20861, 24FC21021, 24FC21026, 24FC21051, 24FC21052, 24FC21056, 24FC21057, 24FC21062, 24KC33486, 24KC33488, 24KC33489, 24KC33490, 24KC33492, 24KC33495, 24KC33505, 24KG58159, 24KG58161, 24KG58162, 24KG58163, 24KG58175, 24KG58176, 24KH93842, 24KH93844, 24KH93846, 24KH93849, 24KH93851, 24KH93859, 24KH94852, 24KH94853, 24KH94854, 24KH95010, 24KH95451, 24KH95459, 24KH95467, 24KH95494, 24KH95498, 24KH96442, 24KH96444, 24KH96472, 24KJ69126, 24KJ69127, 24KJ69142, 24KJ69143, 24KJ69146, 24KJ70078, 24KJ70129, 24KL65170, 24KL65171, 24KL65173, 24KL65184, 24KL65185, 24KM83160, 24KM83163, 24KM83164, 24KQ56162, 24KQ56499, 24KQ56501; h) Unit numbers: 24KH95875, 24KH95877, 24KH95878, 24KM83467, 24KM83474, 24KM83475. RECALLING FIRM/MANUFACTURER American Red Cross, River Valley Region, Louisville, KY, by facsimile on August 24, 2003, and by letters, dated September 3, 2003 and October 7, 2003. Firm initiated recall is complete. REASON Blood products, collected from a donor whose arm preparations were not adequately prepared, were distributed. VOLUME OF PRODUCT IN COMMERCE 589 units. DISTRIBUTION Nationwide. _______________________________ PRODUCT Source Plasma. Recall # B-1615-4. CODE Unit numbers: 7G2898, 8MW310, 8MW498, 95D691, 95D796, 95D967, 95E040, 95E289, 95E349, 95E539, 95E578, 95E716, 95F464, 9NS158, 9NS265, 9NS594, 9SW771, 9SW999, 9V5741, 9V5801, BJBZNC, BJCDLK. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Oklahoma City, OK, by facsimile dated April 20, 2001 and by email on May 16, 2003. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor who had been permanently deferred due to drug use, were distributed. VOLUME OF PRODUCT IN COMMERCE 22 units. DISTRIBUTION IL, and Germany. _______________________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-1645-4. CODE Unit number: 04KM46478. RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA, by letters dated April 13, 2004, and May 4, 2004. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VT. _______________________________ PRODUCT Red Blood Cells (Apheresis), Leukoreduced. Recall # B-1764-4. CODE Units 301878101, 301878107, 301878159. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems Inc., Fargo, ND, by letter on December 19, 2003. Manufacturer: United Blood Services, Bismarck, ND. Firm initiated recall is complete. REASON Blood products, collected in a manner that may have compromised their sterility, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units from 3 doubles. DISTRIBUTION CA, NJ, and ND. _______________________________ PRODUCT Platelet Pheresis, Leukoreduced. Recall # B-1774-4. CODE Units: 5479032A, 5479032B, 5479032C, 5479080A, 5479080B, 5479080C. RECALLING FIRM/MANUFACTURER Coral Blood Services Inc. Bangor, ME, by telephone on May 11, 2004 and letter on May 12, 2004. Firm initiated recall is complete. REASON Blood products, collected from a donor who was taking the medication Proscar, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION ME. _______________________________ PRODUCT Source Plasma. Recall # B-1796-4. CODE Units DPDCDL, DPDCGV, DPDCWT, DPDDCZ, DPDDXW, DPDDRY. RECALLING FIRM/MANUFACTURER International Bio Resources, LLC, Milwaukee, WI, by facsimile dated September 25, 2002. Firm initiated recall is complete. REASON Source Plasma, collected from an ineligible donor, was distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION IL. _______________________________ PRODUCT Platelets Pheresis, Leukocytes Reduced. Recall # B-1798-4. CODE Unit number: G98916. RECALLING FIRM/MANUFACTURER Northern Illinois Blood Bank, Inc., Rockford, IL, by telephone on June 4, 2004. Firm initiated recall is complete. REASON Blood product, contaminated with coagulase-negative Staphylococcus, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________________ PRODUCT a) Platelets. Recall # B-1821-4; b) Platelets, Leukocytes Removed. Recall # B-1822-4; c) Platelets, Irradiated. Recall # B-1823-4; d) Fresh Frozen Plasma. Recall # B-1824-4; e) Plasma, Frozen. Recall # B-1825-4. CODE a) Unit numbers: 49Y67247, 49F97629, 49F97919, 49S74852, 49Y46256, 49L86761, 49GF08210, 49L86831, 49G75024, 49S77099, 49S78483, 49LJ36776, 49Y66975, 49Y68019, 49LR07035, 49M29798, 49LF47660, 49S88013, and 49G97186; b) Unit numbers: 49LR25697, 49GF65893, 49M40747, 49GF66168, 49GF66163, 49GG08274, 49GG08288, 49Y83947, 49LR23218, 49LR23574, 49GG07218, 49LR26552, 49Y88280, 49M43638, and 49GG08308; c) Unit number: 49GG06960; d) Unit numbers: 49LW09875, 49LR25697, 49M40654, 49GF65893, 49M40747, 49GF65928, 49LW10123, 49GF66168, 49GF66163, 49Y86783, 49Y86768, 49GF66283, 49GG08274, 49GG08308, 49GG08288, 49GF66711, 49Y43034, 49G67557, 49GF02183, 49GF02368, 49S74472, 49GF12916, 49S77778, 49LJ36776, 49LG35118, 49GF32092, 49Y68019, 49LR05986, 49X74064, 49S88013, 49Y70271, 49GF44164, 49M33702, 49GF59138, 49GF59374, 49GG03425, 49Y83947, 49M37476, 49GF62809, 49LR23218, 49LR23574, 49M38005, 49M37999, 49M37998, 49GF64155, 49GG06960, 49S97285, 49GG07218, 49GG07494, 49GG07480, 49W37522, 49M40192, 49Y88280, 49GF68833, 49M43638, 49GF70875, 49Y89926, 49GF71467, 49GF72747, and 49GN14868; e) Unit numbers: 49LJ41837. RECALLING FIRM/MANUFACTURER American Red Cross, Southwest Region, Tulsa, OK, by telephone on April 10, 2003 and by letters dated April 16, 18, 21, and May 20, 2003, and by facsimile dated July 2, 2004. Firm initiated recall is complete. REASON Blood products, corresponding to a unit of clotted Red Blood Cells, were distributed. VOLUME OF PRODUCT IN COMMERCE 96 units. DISTRIBUTION UT, IL, OK, and TX. _______________________________ PRODUCT Source Plasma. Recall # B-1858-4. CODE Units 9NS964, 82P211, 82O863, 82O161, 82N548, 82J462, 82J334, 82J270, 82I921, 82I853, 8ZI158, 8ZH186, 8ZH080, 8ZG902, 8ZG807, 8ZG379, 8ZG293, 8ZG021, 8ZF932, 8ZE634, 8I5722, 8I5566, 8I5394, 8I5140, 8I5037, 8I4627, 8I3735, 8I3603, 8I3444, 8I2822, 8I2768, 8I2552, 8I2381, 8I2166, 8I2025, 8I1615, 8I1499, 8I1080, 71A482, 71A387, 709879, 709421, 7CY967, 7CY849, 7CY746, 6CV867, 6CV756, 6CV552, 6CU454, 6CU311, 6CU227, 6CU008, 6CT900, 6CT664, 6CT570, 6CS303, 6CR529, 6CQ220, 04L394, 04L213, 04L106, 04K740, 04K379, 04K012, 04J363, 04J165, 04J055, 04I723, 04I429, 04H960, 04H848, 04H498, 04H324, 04H196, 04G627, 04G323, 04D951, 04D774, 04D053, 04C584, 04C404, 04C326, 04C054, 04B922, 04B810, 04B691, 04B571, 04B493, 04B223, 04B170, 04A989, 04A918, 04A386, 04A140, 04A070, 038429, 038146, YFU655, YFU568, YFU336, YFU148, YFU022, YFQ795, YFQ662, YFQ439, YFQ249, YFQ048, YFT956, YFO756, YFN863, YFN721, YFM886, YFM745, YFL980, V07334, V07175, V06914, V06763, V06332, V06010, V05370, V05239, V04958, V04820, V04566, V04463, V03972, V03858, V03596, V00914, UG0107, UGZ800, UGZ578, UGZ364, UGY603, UGY517, RLS382, RLS104, RLR352, RLR151, RLQ885, RLQ566, RLQ451, RLP664, UGT030, UGS796, UGS671, UGS399, UGS232, UGS006, UGR245, UGQ309, RLP223, RLP117, RLO745, RLO595, S3P848, S3N929, S3N666, S3N371, S3N146, S3M426, S3M215, S3M018, S3L422, S3L285, S3K939, S3K134. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Oklahoma City, OK, by letters dated September 26, and September 27, 2001. Firm initiated recall is complete. REASON Source Plasma, collected from a donor who engaged in high-risk behavior, was distributed. VOLUME OF PRODUCT IN COMMERCE 168 DISTRIBUTION NC, France, and Germany. _______________________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-1860-4. CODE Unit numbers: 38H84546, 38FE77835. RECALLING FIRM/MANUFACTURER American Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on April 27, 2004. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IN. _______________________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-1864-4. CODE Unit 21K21241. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Portland, OR, by telephone on May 23, 2003, and by letter dated June 2, 2003. Firm initiated recall is complete. REASON Blood product, which was collected from a donor who had an unacceptable hemoglobin at the time of donation, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WA. _______________________________ PRODUCT Fresh Frozen Plasma. Recall # B-1865-4. CODE Unit 20GR16226. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Boise, ID, by telephone on February 21, 2003, and by letter dated March 17, 2003. Firm initiated recall is complete. REASON Blood product, which was collected from a donor who had received the typoid vaccination, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MT. _______________________________ PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-1873-4. CODE unit numbers 23149-4917 (distributed as two split units) and 23149-4931. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 7, 2003. Manufacturer: Blood Systems, Inc., Billings, MT. Firm initiated recall is complete. REASON Blood products, for which documentation of irradiation was incomplete, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MT. _______________________________ PRODUCT Platelets. Recall # B-1875-4. CODE Units 4229844, 4229846, 4229850, 4229880. RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated December 9, 2002. Firm initiated recall is complete. REASON Blood products, which yielded a platelet count that was below the acceptable limit, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION AK. _______________________________ PRODUCT Red Blood Cells Frozen. Recall # B-1882-4. CODE unit 71Z69719-8 RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Center, Gainesville, FL, by facsimile on December 23, 2003. Firm initiated recall is complete. REASON Blood product, which was manufactured using expired glycerol solution, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION FL. _______________________________ PRODUCT a) Red Blood Cells, Recall # B-1883-4; b) Platelets, Recall # B-1884-4; c) Fresh Frozen Plasma. Recall # B-1885-4. CODE a) Units 11GK17618 and 11GK11191; b) Unit 11GK17618; c) Units 11GK17618 and 11GK11191. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, St. Louis, MO, by telephone on April 29, 2003, or by letter dated April 28,2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who admitted to engaging in multiple high risk behaviors, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION MO, and CA. _______________________________ PRODUCT Recovered Plasma. Recall # B-1886-4. CODE Unit 11GQ51677. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, St. Louis, MO, by facsimile on February 20, 2003. Firm initiated recall is complete. REASON Blood product, which was collected from a donor who was at increased risk for Creuztfeldt Jakob Disease (CJD) due to having lived in Europe between 1984 - 1987, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Switzerland. _______________________________ PRODUCT Platelets Pheresis, Leukocytes Reduced. Recall # B-1888-4. CODE Unit number 04FP70069. RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by telephone on May 8, 2004, and by letter dated May 17, 2004. Firm initiated recall is complete. REASON Blood product, collected in an apheresis collection kit that had exceeded the acceptable time period for use, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MA. _______________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced. Recall # B-1889-4; b) Platelets, Leukocytes Reduced. Recall # B-1890-4; c) Recovered Plasma. Recall # B-1891-4. CODE a), b), and c) unit number 33GE80466. RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT, by facsimile on April 28, 2004, telephone on May 28, 2004, and letter on June 2, 2004. Firm initiated recall is complete. REASON Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD). VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CT, and CA. _______________________________ PRODUCT a) Red Blood Cells. Recall # B-1892-4; b) Fresh Frozen Plasma. Recall # B-1893-4. CODE a) and b) Unit number 4227074. RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated November 25, 2002. Firm initiated recall is complete. REASON Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD). VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AK. _______________________________ PRODUCT Fresh Frozen Plasma. Recall # B-1894-4. CODE Unit number KC51510. RECALLING FIRM/MANUFACTURER HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA, by telephone on January 23, 2004, and by letter on February 2, 2004. Firm initiated recall is complete. REASON Blood product, associated with an unit of Red Blood Cells that contained clots, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced. Recall # B-1902-4; b) Fresh Frozen Plasma. Recall # B-1903-4. CODE a) and b) Unit number 11GJ26528. RECALLING FIRM/MANUFACTURER The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by letter on February 3, 2003. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AL, and PR. _______________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1910-4; b) Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-1911-4. CODE a) Unit 49FF51189; b) Unit 49FF50655. RECALLING FIRM/MANUFACTURER Recalling Firm: American National Red Cross, Southwest Region, Tulsa, OK, by facsimile on November 14, 2003. Manufacturing Firm: American Red Cross Blood Services, Southwest Region, College Station, TX. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OK, and TX. _______________________________ PRODUCT Source Plasma. Recall # B-1916-4. CODE Units FLHSHK , FLDRWN, FLDRVJ, FLDRQG, FLDRPH , FLDRBK, FLDQLL, FLDQJX, FLDQHY , FLDQGB, FLDQDM, FLDPSC, FLDPRC, FLCPTM, FLCPRV, FLCPRC, FLCPBM, and FLCNWF. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Waco, TX, by letter dated March 21, 2003. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 18 units. DISTRIBUTION IL. RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III _______________________________ PRODUCT Human Corneal Tissue. Recall # B-1714-4. CODE 2004-040OS, 2004-040OD. RECALLING FIRM/MANUFACTURER Great Plains Lions Eye Bank, Inc., Lubbock, TX, by letter dated June 7, 2004. Firm initiated recall is complete. REASON Human tissues for transplantation, procured from a donor whose next of kin was not asked multiple questions regarding high-risk behavior questions during the Medical/Social History Interview, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 tissues. DISTRIBUTION MO. _______________________________ PRODUCT Red Blood Cells. Recall # B-1820-4. CODE Unit number: 49LF47704. RECALLING FIRM/MANUFACTURER American Red Cross, Southwest Region, Tulsa, OK, by telephone on April 10, 2003. Firm initiated recall is complete. REASON Blood products, corresponding to a unit of clotted Red Blood Cells, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________________ PRODUCT a) Red Blood Cells. Recall # B-1862-4; b) Red Blood Cells Leukocytes Reduced. Recall # B-1863-4. CODE a) Unit 2421944401; b) Unit 242192958. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Rapid City, SD, by telephone on April 2, 2003. Firm initiated recall is complete. REASON Blood products, which were incorrectly tested for the presence of red cell antigens, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION WY. _______________________________ PRODUCT Source Plasma. Recall # B-1866-4. CODE Unit XG0013823. RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Port Arthur, TX, by facsimile on April 16, 2001. Firm initiated recall is complete. REASON Blood product, which was collected from a donor whose health history screening was not adequately performed, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. _______________________________ PRODUCT Source Plasma. Recall # B-1867-4. CODE Unit XN0002165. RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Port Arthur, TX, by facsimile on April 16, 2001. Firm initiated recall is complete. REASON Blood product, which was collected from a donor whose health history screening was not adequately performed, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. _______________________________ PRODUCT Source Plasma, Recall # B-1869-4. CODE Unit number XG0019114. RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Port Arthur, TX, by facsimile on April 16, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Spain. _______________________________ PRODUCT Source Plasma, Recall # B-1870-4. CODE Unit number XA0002443. RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Port Arthur, TX, by facsimile on April 16, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Spain. _______________________________ PRODUCT Source Plasma, Recall # B-1871-4. CODE Unit number XA0002340. RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Port Arthur, TX, by facsimile on April 16, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Spain. _______________________________ PRODUCT Source Plasma, Recall # B-1872-4. CODE Unit number XG0011720. RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Port Arthur, TX, by facsimile on April 16, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Spain. _______________________________ PRODUCT Platelets Pheresis, Leukocytes Reduced. Recall # B-1887-4. CODE Unit number 04GR22891 (distributed as two split units). RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by telephone on June 18, 2004, and by letter dated June 24, 2004. Firm initiated recall is complete. REASON Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MA. _______________________________ PRODUCT Platelets. Recall # B-1901-4. CODE Unit number 6034421. RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK, by letter on May 28, 2003. Firm initiated recall is complete. REASON Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I _______________________________ PRODUCT Minerva Patient Lift, model ML-20; this lift has a passive lifting unit. Recall # Z-1381-04. CODE Model ML-20: serial numbers 952056, 952057, 952112, 952113, 952114, 952115, 952116, 952117, 962118, 952119, 952120, 952121, 962214, 962215, 962216, 962217, 962218, 962235, 962236, 962238, 962239, 962240, 962241, MPBX 97052M563, MPBX97052M564, MPBX97052M565, MPBX97052M566, MPBX97052M567, MPBX97052M568, MPBX97052M569, MPBX97052M570, MPBX97052M571, MPBX97052M572, MPBX97052M573, MPBX97052M574, MPBX97052M575, MPBX97052M576, MPBX97052M577, MPBX97052M578, MPBX97052M579, MPBX98022M649, MPBX98022M650, MPBX98022M651, MPBX98022M652, MPBX98022M653, MPBX98022M676, MPBX98022M677, MPBV00032M1013, MPBV00072M1074. RECALLING FIRM/MANUFACTURER Medibo N.V., Hanmont, Achel, Belgium, by letters dated August 6, 2004. Firm initiated recall is ongoing. REASON The hanger bar may detach from the jib yoke, the M8 bolt in the foot pedal assembly may come loose, and some units may have faulty actuator brackets on the mast assembly, resulting in the patient lift becoming unstable and allowing the patient to fall. VOLUME OF PRODUCT IN COMMERCE 64 units. DISTRIBUTION CA, FL, LA, MA, NH, NJ, NY, OH, OR and PA. RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II _______________________________ PRODUCT STS-T Mobile x-ray system used with the STS-T lithotripter. Model STS-T. Recall # Z-0884-04. CODE None provided. RECALLING FIRM/MANUFACTURER Medstone International, Inc., Aliso Viejo, CA, by letter on June 11, 2004. Firm initiated recall is complete. REASON Units are defective in that the identification and certification labels were inadequate or missing. The beam limiting device was not appropriate for general purpose radiographic procedures and the beam limiting device could ot collimate down to 125 square centimeters or less as required. VOLUME OF PRODUCT IN COMMERCE 30 units. DISTRIBUTION Nationwide. _______________________________ PRODUCT iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device. The device is shipped one each per wooden pallet with wooden sides and top retained by reusable bands. Recall # Z-1383-04. CODE Catalog No.s IT000101-IT000148 (inclusive), Vehicle Identification Numbers (VINs): 020404-000347, 020104-000309, 020504-000357, 021203-000308, 020204-000331, 020104-000314, 020104-000318, 021203-000301, 020304-000335, 020104-000310, 020404-000341, 021203-000299, 020204-000330, 020104-000322, 020204-000332, 020404-000350, 020404-000348, 020304-000340, 020404-000346, 020404-000342, 021203-000307, 020204-000333, 020104-000319, 021203-000304, 020404-000352, 020304-000337, 020304-000336, 020504-000356, 020404-000349, 021203-000305, 020604-000360, 020104-000317, 021203-000306, 020504-000358, 020404-000345, 020504-000354, 020304-000334, 020304-000338, 020404-000344, 020404-000351, 020504-000355, 020104-000323, 020104-000324, 021103-000291, 021203-000300, 020304-000339, 020404-000343, 020504-000359, 020604-000363, 020604-000364, 020604-000365, 020604-000366, 020604-000367, 020604-000368, 020604-000362, 021103-000290, 021103-000295, 020104-000315, 020104-000316, 020104-000320, 020104-000311, 020104-000313, 020204-000329, 020504-000353, 020104-000312, 020604-000361, 021003-000280, 020204-000328, 020104-000321, 020204-000326, 021203-000297, 021203-000298, 021203-000303, 020204-000327, 021103-000294, 021103-000286, 021103-000287, 021003-000273, 021103-000282, 021103-000292, 021103-000293, 021003-000276, 021003-000277, 021103-000285, 021103-000289, 020204-000325, 021103-000296, 021003-000278, 021003-000281, 021003-000272, 021003-000279, 021003-000274, 021003-000275, 021103-000283, 021103-000288, 021103-000284, 021203-000302. RECALLING FIRM/MANUFACTURER Independence Technology LLC, Warren, NJ, by telephone on July 2, 3, & 4, 2004 and by letters from July 5, 6, & 8, 2004. Firm initiated recall is ongoing. REASON IBOT Mobility System may tip over due to malfunction in power base. VOLUME OF PRODUCT IN COMMERCE 81 units. DISTRIBUTION Nationwide, UK, Ireland, and New Zealand. _______________________________ PRODUCT The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pumps). The Model 8540 Catheter Access Port Kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump, infusion, implanted, programmable under product code LKK. Recall # Z-1384-04. CODE CS0293. RECALLING FIRM/MANUFACTURER Medtronic Inc., Neurological & Spinal Division, Columbia Heights, MN, by letter on July 23, 2004. Firm initiated recall is ongoing. REASON The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of product: CS0293. VOLUME OF PRODUCT IN COMMERCE 405 kits. DISTRIBUTION Nationwide and New Zealand. _______________________________ PRODUCT a) Weck Hemoclip Traditional Ligating Clips, Ref No. 523170 Hemoclip, 15 Large Tantalum Clips/Cartridge and Ref. No. 523370 Hemoclip 10 Large Tantalum Clips/Cartridge. Recall # Z-1385-04; b) Weck Atrauclip Ligating Clips, Ref. No. 121505 Atrauclip, 15 Large Titanium Clips/Cartridge and Ref. No. 121506 Atrauclip, 10 Large Titanium Clips/Cartridge. Recall # Z-1386-04; c) Weck Hemoclip Traditional Ligating Clips, Ref. No. 523770 Hemoclip, 15 Large Titanium Clips/Cartridge, and Ref. No. 523870 Hemoclip 10 Large Titanium Clips/Cartridge. Recall # Z-1387-04; d) Weck Hemoclip Traditional Ligating Clips, Ref. No. 523171 Hemoclip, 10 Large Tantalum Clips/Cartridge (Non- Sterile) and Ref. No. 523371 Hemoclip, 15 Large Tantalum Clips/Cartridge (Non-Sterile). Recall # Z-1388-04; e) Weck Hemoclip Traditional Ligating Clips, Ref. No. 523771 - Hemoclip, 15 Large Titanium Clips/Cartridge (Non-Sterile) and Ref. No. 523871- Hemoclip, 10 Large Titanium Clips/Cartridge (Non-Steile). Recall # Z-1389- 04; f) Weck Hemoclip Traditional Ligating Clips, Ref No. 523470 Hemoclip, 15 Large Stainless Steel Clips/Cartridge and Ref. No. 523670 Hemoclip, 10 Large Stainless Steel Clips/Cartridge. Recall # Z-1390-04; g) Weck Hemoclip Plus Ligating Clips, Ref. No. 533702 Hemoclip Plus, 25 Medium Titanium Clips, No Tape; Ref. No. 533737 Hemoclip Plus, 25 Small Titanium Clips/Cartridge, No Tape and Ref. No. 533872 Hemoclip Plus, 10 Large Titanium Clips/Cartridge, No Tape. Recall # Z-1391-04; h) Weck Hemoclip Plus Ligating Clips, Ref. No. 533735 and 534735 Hemoclip Plus, 25 Small Titanium Clips, Cartridge; Ref. No. 533870 Hemoclip Plus, 10 Large Titanium Clips/Cartridge and Ref. No. 533700 Hemoclip Plus, 25 Medium Titanium Clips/Cartridge. Recall # Z- 1392-04. CODE a) All lots manufactured between 2001-8 through 2002-12 for the 15 and 10 Large Tantalum Clips and additional Lots 763010, 763011, 769345 and 831864 for the 10 Large Tantalum Clips; b) All lots manufactured between 2001-8 through 2002-12; c) All lots manufactured between 2001-8 through 2002-12 for the 15 and 10 Large Titanium Clips and additional lots 799983, 816529, 826816, and 840190 for the 10 Large Titanium Clips; d) All lots manufactured between 2001-8 through 2002-12 for the 10 and 15 Large Tantalum Clips and lot 763013 for the 15 Large Tantalum Clips; e) All lots manufactured between 2001-8 throught 2002-12 for the 15 and 10 Large Titanium Clips and lots 880608 and 944135 for the 10 Large Titanium Clips; f) All lots manufactured between 2001-8 thorugh 2002-12 for 15 Large and 10 Large Stainless Steel Clips and lot 809026 for the 10 Large Stainless Steel Clips; g) All lots manufactured between 2001-8 thorugh 2002-12 for all three products and lot 763100 for 25 Medium Titanium Clips, lots 763102 and 949861 for 25 Small Clips and lot 814007 for 10 Large Titanium Clips; h) All lots manufactured between 2001-8 through 2002-12 for all three products and lots 738967, 763871 and 714124 for 25 Small Titanium Clips; lots 703251, 722666 and 825952 for 10 Large Titanium Clips and lots 738966, 754641 and 824238 for 25 Medium Titanium Clips. RECALLING FIRM/MANUFACTURER Weck, NC, by letter beginning October 24, 2003. Form initiated recall is complete. REASON Hole in the sterile unit blister pack that could compromise sterility. VOLUME OF PRODUCT IN COMMERCE 91,869 units. DISTRIBUTION Nationwide and Internationally. _______________________________ PRODUCT a) SMV FX-40 Nuclear Camera. Recall # Z-1393-04; b) SMV FX-80 Nuclear Camera. Recall # Z-1394-04. CODE a) 00000000000194, 00000000000222, 0070090040-100, 0070090040-101, 0070090040-105, 0070090040-111, 0070090040-113, 0070090040-114, 0070090040-117, 0070090040-120, 0070090040-122, 0070090040-128, 0070090040-129, 0070090040-131, 0070090040-132, 0070090040-133, 0070090040-134, 0070090040-136, 0070090040-137, 0070090040-139, 0070090040-144, 0070090040-147, 0070090040-148, 0070090040-149, 0070090040-151, 0070090040-154, 0070090040-156, 0070090040-157, 0070090040-159, 0070090040-160, 0070090040-166, 0070090040-171, 0070090040-175, 0070090040-177, 0070090040-182, 0070090040-183, 0070090040-185, 0070090040-189, 0070090040-190, 0070090040-192, 0070090040-193, 0070090040-195, 0070090040-196, 0070090040-197, 0070090040-198, 0070090040-199, 0070090040-200, 0070090040-201, 0070090040-202, 0070090040-204, 0070090040-205, 0070090040-206, 0070090040-207, 0070090040-208, 0070090040-210, 0070090040-211, 0070090040-212, 0070090040-213, 0070090040-215, 0070090040-216, 0070090040-217, 0070090040-219, 0070090040-221, 0070090040-222, 0070090040-939; b) 00000000000172, 00000000000173, 00000000000188, 00000000000203, 00000000000209, 00000000000214, 00000000000223, 0070090080-103, 0070090080-106, 0070090080-107, 0070090080-112, 0070090080-115, 0070090080-116, 0070090080-123, 0070090080-124, 0070090080-125, 0070090080-126, 0070090080-127, 0070090080-138, 0070090080-141, 0070090080-146, 0070090080-150, 0070090080-152, 0070090080-158, 0070090080-161, 0070090080-162, 0070090080-163, 0070090080-164, 0070090080-165, 0070090080-167, 0070090080-168, 0070090080-170, 0070090080-172, 0070090080-173, 0070090080-179, 0070090080-180, 0070090080-188, 0070090080-203, 0070090080-209, 0070090080-96, 0070090080-P298. RECALLING FIRM/MANUFACTURER General Electric Med Systems, Waukesha, WI, by Field Modification Instruction beginning on March 23, 2004. Firm initiated recall is ongoing. REASON The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become loose, fail, or back out. VOLUME OF PRODUCT IN COMMERCE 96 units. DISTRIBUTION Nationwide. _______________________________ PRODUCT a) Magnetom Avanto MRI System, Model 7391167. Recall # Z- 1395-04; b) Magnetom Harmony MRI System Model number 7106714. Recall # Z-1396-04; c) Magnetom Harmony MRI System Model number 5751438, Recall # Z-1397-04; d) Magnetom Symphony MRI System, Model 7106557. Recall # Z- 1398-04; e) Magnetom Symphony MRI System, Model 7104594. Recall # Z- 1399-04; f) Magnetom Sonata MRI System, Model 7388148. Recall # Z- 1400-04; g) Magnetom Sonata MRI System, Model 7104719. Recall # Z- 1401-04; h) Magnetom Sonata MRI System, Model 7106425. Recall # Z- 1402-04; i) Magnetom Trio MRI System, Model 7106441. Recall # Z- 1403-04; j) Magnetom Trio MRI System, Model 7387074. Recall # Z- 1404-4. CODE a) Serial numbers 25001 25129; b) Serial number 10502; c) Serial number 15002; d) Serial numbers 14018 and 14108; e) Serial numbers 22009, 22016, and 22081; f) Serial numbers 16502 and 16509; g) Serial numbers 21151 and 21223; h) Serial numbers 21921; i) Serial numbers 20500, 20502, and 20507; j) Serial numbers 20554, 20561, and 20569. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern PA, by letter on July 28, 2004. Firm initiated recall is ongoing. REASON An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows. VOLUME OF PRODUCT IN COMMERCE 41 units. DISTRIBUTION Nationwide. _______________________________ PRODUCT Guardian Distal Femur Axial Pin. Recall # Z-1405-04. CODE Part No. 25002111, Serial No. 02217952 Part No. 25002112, Serial No. 01214391 Part No. 25002112, Serial No. 01215073 Part No. 25002113, Serial No. 01214533 Part No. 25002114, Serial No. 01215034 Part No. 25002114, Serial No. 01215074. RECALLING FIRM/MANUFACTURER Wright Medical Technology, Inc, Arlington, TN, by letter dated July 14, 2004. Firm initiated recall is ongoing. REASON Potential for self-locking axial pin to dislodge and back out. VOLUME OF PRODUCT IN COMMERCE 44 units. DISTRIBUTION Nationwide, Ontario, and Taiwan, ROC. _______________________________ PRODUCT a) Jackson-Pratt Hemaduct, 15 Fr round, full duct silicone wound drain; a sterile, single use only, Rx device, individually packaged, 10 drains per box, 8 boxes per case; catalog #JP-HUR880; catalog #JP-HUR880, Recall # Z-1406-04; b) Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a component of the wound drain system, individually packaged, 10 reservoirs per case, catalog #SU130-1000; Recall # Z-1407-04. CODE a) Lot 1040909; b) Lots 1040877, 1040879, 1040991, and 1040992. RECALLING FIRM/MANUFACTURER Cardinal Health, McGaw Park, IL, by telephone and letters on July 28, 2004. Firm initiated recall is ongoing. REASON The products labeled as sterile are not sterile. VOLUME OF PRODUCT IN COMMERCE 170 cases. DISTRIBUTION FL, AZ, NJ, and Canada. _______________________________ PRODUCT a) Peritoneal Lavage Kits, Model number AK-09000. Recall # Z-1408-04; b) Peritoneal Lavage Kits, Model number AK-09001. Recall # Z-1409-04. CODE a) Lot numbers: RF3111181 exp. 7/06, RF4012217 exp. 9/06, RF4012309 exp. 8/06, RF4012781 exp. 8/06, RF4023104 exp. 8/06, RF4034175 exp. 9/06, RF4034346 exp. 9/06, RF4034553 exp. 9/06, RF4055424 exp. 11/06, RF4055592 exp. 12/06, RF4055908 exp. 11/06, and RF4066874 exp. 12/06; b) Lot numbers: RF3111152 exp. 5/08, RF3121739 exp. 8/06, RF4012282 exp. 7/08, RF4012530 exp. 7/08, RF4034376 exp. 10/06, RF4034554 exp. 11/08, RF4045029 exp. 11/08, and RF4066325 exp. 1/09. RECALLING FIRM/MANUFACTURER Arrow International Inc., Reading, PA, by letter on August 9, 2004. Firm initiated recall is ongoing. REASON Wrong introducer needle in some kits. VOLUME OF PRODUCT IN COMMERCE 8,090 units. DISTRIBUTION Nationwide and Internationally. _______________________________ PRODUCT Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable - Single Use Only, Rx Only, Sterile EO, Order Number EZSP-25-10-FC. Recall # Z-1410-04. CODE Lot Number R1688574. RECALLING FIRM/MANUFACTURER Wilson-Cook Medical Inc., Winston-Salem, NC, by visit on January 30, 2003. Firm initiated recall is complete. REASON Label contains the 'Sterile EO' symbol, however the device is provided non-sterile. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION CT, HI, LA, MO, and PA. ____________________________ PRODUCT Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026. Recall # Z-1411-04. CODE Arthrotek lots 049130, 300470, 278290 and 452840. Biomet lots 300450 and 228320. RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN, by letters dated July 12, and July 15, 2004. Firm initiated recall is ongoing. REASON The cautery cover cap may become dislodged during shipping or handling, the cautery switch may be activated and the cautery may melt or burn through the packaging pouch. VOLUME OF PRODUCT IN COMMERCE 130 units. DISTRIBUTION Nationwide. _______________________________ PRODUCT a) ConMed Stealth Coated Laparoscopic Electrodes with 3/32 pin (60-5158 series) as follows: Cat. #60-5158-027 Spatula 5 mm x 27 cm; Cat #60-5158-032 - Spatula 5 mm x 32 cm; Cat. #60-5158-044 - Spatula 5 mm x 44 cm; Cat #60-5158-127 - L Hook 5 mm x 27 cm; Cat #60-5158-132 - L Hook, 5 mm x 32 cm; Cat #60-5158-144 - L Hook 5 mm x 44 cm; Cat #60-5158-232 - J Hook 5mm x 32 cm; Cat. #60-5158-244 - J Hook 5mm x 44 cm; Cat #60-5158-927 - Needle 5 mm x 27 cm; Cat #60-5158-932 - Needle 5 mm x 32 cm; Recall # Z-1412-04; b) ConMed Stealth Coated Laparoscopic Electrodes with 4mm pin (60-5158 series) as follows: Cat. #60-5158-034 Spatula, 5 mm x 32 cm; Cat #60-5158-432 L Hook 5 mm x 32 cm; Cat #60-5158-934 - Needle 5mm x 32 cm. Recall # Z-1413-04. CODE a) Lot #s 0309121, 0310301, 0401051, 0404271, 0405031; Lot #s 0309011, 0309111, 0401121, 0402031, 0402271, 0404131, 0405031, 0406071; Lot #s 0309151, 0403121; Lot #s 0309021, 0309151, 0310301; Lot #s 0308071, 0308211, 0310081, 0311031, 0311101, 0401051, 0402031, 0402271, 0403121, 0404131; Lot #s 0308261, 0310061, 0310081, 0311101, 0402031, 0403031, 0403121, 0406071; Lot #s 0309121, 0310301, 0402181, 0404301; Lot #s 0309121, 0310081, 0402271, 0404301; Lot # 0309021; Lot #0308111, 0309021, 0310081, 0311101, 0401121, 0402181, 0403121; b) Lot #s 0309121; Lot #s 0308071, 0309021, 0309151, 1121; Lot #s 0309111. RECALLING FIRM/MANUFACTURER ConMed Corporation, Utica, NY, by letters dated August 9, 2004. Firm initiated recall is ongoing. REASON Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock. VOLUME OF PRODUCT IN COMMERCE 6,472 units. DISTRIBUTION Nationwide and Internationally. 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