September 20, 2000 00-38RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Jensen's Seattle Style Smoked Wild Pacific King Salmon, in clear plastic. Recall #F-845-0. CODE Lot #000623. MANUFACTURER Jensen's Old Fashioned Smokehouse, Inc., Seattle, Washington. RECALLED BY Manufacturer, by telephone on July 24, 2000, and by press release on July 25, 2000. Completed recall resulted from sample analysis and follow-up by the Washington State Department of Agriculture. DISTRIBUTION Washington state. QUANTITY 400 pounds were distributed. REASON Product is contaminated with Listeria monocytogenes. ________ PRODUCT Cold smoked fish: a) Assorted Plate in 8 oz. and 16 oz. packages, containing Siomga, Captain, and Trout, coded: 411, 511, 611, 811, 911, 1011, 1111, 1211, 1311, 1511, 1611, 1711, 1811, 1911, 2011, 2211, 2311, 2411, 2511, 2611, 2711, 2911, 3011, 112, 212, 312, 412, 612, 712, 812, 912 (distributed from 11/4/99-12/9/99) b) Smoked Captain (Sea Bass) in 0.5 lb. packages, coded: 410, 510, 610, 710, 810, 910, 1110, 1210, 1310, 1410, 1510, 1610, 1810, 1910, 2010, 2110, 2210, 2310, 2510, 2610, 2710, 2810, 2910, 3010, 111, 211, 311, 411, 511, 611, 811, 911, 1011, 1111, 1211, 1311, 1511, 1611, 1711, 1811, 1911, 2011, 2211 (distributed from 10/4/99-11/22/99) c) Smoked Captain bulk pack, coded 1111, distributed 11/11/99 d) Lake Trout in 0.5 lb. packages, coded: 226, 236, 246, 256, 266, 286, 296, 306, 17, 27, 37, 57, 67, 77, 87, 97, 107, 127, 137, 147, 157, 167, 177, 187, 197, 207, 217 (distributed from 6/22/99-7/26/99) e) Lake Trout, bulk pack, coded: 2710 distributed 11/1/99 f) Smoked Royal Trout in 3 oz. and 8 oz. packages, coded: 511, 611, 811, 911, 1011, 1111, 1211 (distributed from 11/5/99 through 11/12/99) g) Smoked Turbot in 0.5 lb. package, coded: 1611, 1711, 1811, 1911, 2011, 2211, 2311, 2411, 2511, 2611, 2711, 2911 (distributed from 11/16/99- 11/29/99) h) Smoked Turbot in bulk package, code: 1511 (distributed from 11/17/99- 12/9/99) i) Imperial European Style Smoked Salmon in 3 oz. and 8 oz. packages, coded: 911, 1011, 1111, 1211, 1311, 1511, 1611, 1711, 1811, 1911, 2011, 2211 (distributed from 11/9/99-11/22/99) j) Smoked Siomga coded: 2710 (distributed from 10/27/99-11/12/99) k) Lake Trout, whole eviscerated, coded: 300 l) Captain (Sea Bass), whole eviscerated, coded: 315 m) Siomga, whole eviscerated, coded: 300. Recall #F-863/875-0. CODE See above. MANUFACTURER Royal Baltic, Ltd., Brooklyn, New York. RECALLED BY Manufacturer, by press release on December 23, 1999, by letters on January 7, 2000, and February 8, 2000, and by telephone. Firm-initiated recall ongoing. See also FDA press release P99-34 on December 23, 1999. DISTRIBUTION Nationwide and Russia. QUANTITY Undetermined. REASON Products may be contaminated with Listeria monocytogenes. ________ PRODUCT Greenbank Farms Organic Medium Cheddar Cheese. Recall #F-876-0. CODE All codes on the market at time of recall initiation. MANUFACTURER Bandon Cheese, Inc., Bandon, Oregon. RECALLED BY Stonefelt & Company, Preston, Washington (cutter/packer), by fax on July 24, 2000, and by press release on July 26, 2000, and August 1, 2000. Completed recall resulted from sample analysis and follow-up by the Washington State department of Agriculture. DISTRIBUTION Alaska, Washington state, Oregon, California. QUANTITY 1,260 pounds were distributed. REASON Product is contaminated with Listeria monocytogenes. _______ PRODUCT Asian Boy brand Pickled Leek, in 15-ounce glass jars. Recall #F-877-0. CODE None. MANUFACTURER Mekong Company, Ho Chi Minh City, Vietnam. RECALLED BY BCN Trading Corporation, Brooklyn, New York (importer), by letter dated March 9, 2000 and press release on March 3, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Pennsylvania, Massachusetts, Connecticut, New Jersey, District of Columbia. QUANTITY 200 cases (24 jars per case) were distributed. REASON Product contained undeclared sulfites. ________ PRODUCT Sandwiches: a) Grannyís Country Cupboard Turkey NíSwiss Sub Sandwich #11004B, Net Wt. 5.5 oz.; b) Grannyís Country Cupboard Turkey & Bacon Sub Sandwich #11009B, Net Wt. 4.5 oz.; c) Grannyís Country Cupboard Ham & Cheese Croissant Sandwich #11504C, Net Wt. 5 oz.; d) Grannyís 99 cent Meal Deal Ham & Cheese Sandwich #13205A, Net Wt. 3 3/4 oz.; e) Grannyís Country Cupboard Ham & Cheese Soft Sub Sandwich #16504C, Net Wt. 6 1/2 oz.; f) Grannyís Country Cupboard Ham Turkey Club Soft Sub Sandwich #16505C, Net Wt. 6 1/2 oz.; g) Grannyís Country Cupboard Double Stuff Ham & Cheddar Sandwich #20502E, Net Wt. 7 oz.; h) Grannyís Country Cupboard Double Stuff Smoked Turkey & Swiss Sandwich #20503, Net Wt. 6 oz.; i) Grannyís Country Cupboard Double Stuff Roast Beef N' CoJac Sandwich #20505, Net Wt. 7 oz.; j) Grannyís Country Cupboard Double Stuff Ham & Cheese Sub Sandwich #23101, Net Wt. 10 oz.; k) Grannyís Country Cupboard Double Stuff Turkey & Cheese Sub Sandwich #23102E, Net Wt. 10 oz.; l) Grannyís Country Cupboard Double Stuff Turkey, Beef Club Sandwich #23103E, Net Wt. 10 oz.; m) Grannyís Country Cupboard Deli Combo on White Bread Sandwich #13601B, Net Wt. 5 oz.; n) Grannyís Country Cupboard Ham & Swiss on Rye Bread Sandwich #13602B, Net Wt. 4 oz.; o) Grannyís Country Cupboard Ham & American on White Bread Sandwich #13603B, Net Wt. 5 oz.; p) Grannyís Country Cupboard Turkey & Ham Club on White Bread Sandwich #13605B, Net Wt. 5 oz.; q) Grannyís Deli Combo 8" Submarine Sandwich #23002D, Net Wt. 11.5 oz.; r) Grannyís 8" Ham & Turkey Club Sub Sandwich #23003D, Net Wt. 9 oz.; s) Grannyís Roast Beef NíSwiss 6" Sub WíPeppers & Onions Sandwich #24004C, Net Wt. 7 oz.; t) Grannyís Italian Supreme 8" Sub W' Peppers & Onions Sandwich #23005E, Net Wt. 10 oz. u) Grannyís Country Cupboard Egg Salad on White Bread Sandwich #13502A, Net Wt. 5 oz. Recall #F-878/898-0. CODE All sandwiches made with sliced ham, turkey, and roast beef from 6/28/00 through 7/5/00. MANUFACTURER Landshire Fast Foods of Milwaukee, Inc., Muskego, Wisconsin. RECALLED BY Manufacturer, by memorandum and letter dated July 6, 2000, and by press release issued by The Wisconsin Department of Agriculture on July 7, 2000. Completed recall resulted from sample analysis and follow-up by the Wisconsin Department of Agriculture. DISTRIBUTION Wisconsin, Illinois, Indiana. QUANTITY Approximately 1,300 sandwiches were in distribution at time of recall initiation. REASON Products may be contaminated with Listeria monocytogenes.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Charley's brand Spring Rolls Hot & Spicy Chicken Flavored, 6-ounce and 3- 1/4 ounce sizes. Recall #F-827-0. CODE The code reflects the date of manufacture with the number "12" added to each portion of the date. The last date of manufacture for the improperly labeled product produced 7/21/00: (072100) would be 193312. MANUFACTURER Willow Family Foods, Beaverton, Oregon. RECALLED BY Manufacturer, by telephone on July 24, 2000. Firm-initiated field correction (relabeling) complete. DISTRIBUTION Washington state, Oregon, Idaho, Utah, Arizona, Minnesota, Montana. QUANTITY Approximately 300-500 cases per week are distributed. REASON Product contains undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 40. ________ PRODUCT Zataran's brand Rice Mixes: a) Jambalaya; b) Dirty Rice; c) Spanish Rice; d) Black Beans and Rice; e) Red Beans and Rice; f) Yellow Rice; g) Gravy and Rice; h) Long Grain Rice And Wild Rice; i) Chicken Flavored Rice; j) Black-Eyed Peas and Rice. Recall #F-847/856-0. CODE a) 8C, 9C, 10C, 13C, 14C; b) 9C, 10C, 13C, 14C; c) 25B and 29B; d) 25B; e) 25B, 29B, 1C, 2C, 3C; f) 29B, 1C, 14C; g) 2C; h) 1C; i) 2C, 3C, 8C; j) 2C and 3C. MANUFACTURER Zatarain's, Inc., Gretna, Louisiana. RECALLED BY Manufacturer, by letter on April 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 78,194 cases (12 per case) were distributed. REASON Product is contaminated with pieces of approximately 25 gauge wire ranging from 7-12 mm in length. ________ PRODUCT Fruit Flavor Mini Jelly, in 255-gram flexible plastic bags. Recall #F- 857-0. CODE All product on the market at the time of recall initiation. MANUFACTURER Guangdong Jiangmen Foreign Trade Development Corporation, Guangdong, China. RECALLED BY 282 International Trading, Inc., Brooklyn, New York, by telephone on April 12, 2000. Completed recall resulted from an inspection and follow- up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 80 cases (24 units per case) were distributed. REASON Product contained undeclared FD&C Yellow No. 5. ________ PRODUCT Albertson's Egg Sesame Bread, 1 pound 8 ounces; b) Country Farms Hawaiian Sweet Egg Bread, 1-1/2 pound wide pan loaf. Recall #F-860/861-0. CODE Albertsonís Egg Sesame Bread: All product of Albertsonís Egg Sesame Bread produced prior to the date of 8/15/2000. Country Farms Hawaiian Sweet Egg Bread: All product of Hawaiian Sweet Egg Bread made prior to 8/15/2000 Both products are identifiable through product codes AUG14A22219 AUG14B22219 AUG15A22220 AUG15B22220 AUG17A22222 AUG17B22222 AUG18A22223 AUG18B22223 AUG19A22224 AUG19B22224 AUG21A22226 AUG21B22226 AUG22A22227 AUG22B22227. MANUFACTURER Interstate Brands Corporation NO. 27, Glendale, California. RECALLED BY Manufacturer, by telephone on August 15, 2000. Firm-initiated recall complete. DISTRIBUTION California and Nevada. QUANTITY a) 3,926 units; b) 17,981 units were distributed. REASON Products contain undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT a) Golden State brand Select Mozzarella 100% Natural Cheese, Part Skim b) Golden State brand Select Mozzarella 100% Natural Cheese, Whole Milk, Shredded c) Golden State brand Select Mozzarella 100% Natural Cheese, Whole Milk d) Golden State brand Select Mozzarella 100% Natural Cheese, Part Skim, Shredded e) Golden State brand Select 80% Mozzarella, 10% Provolone, 10% Cheddar, 100% Natural Cheese f) Golden State brand Select Gourmet Blend, Mozzarella/Fontina, 100% Natural Cheese g) Golden State brand Select 100% Whole Milk, Provolone, Natural Cheese h) Golden State brand Select 50% Mozzarella, 50% Provolone, 100% Natural Cheese i) Luzzatti brand Shredded, Whole Milk Mozzarella Cheese j) Luzzatti brand Shredded, Part Skim, Mozzarella Cheese k) Luzzatti brand Diced, Part Skim, Mozzarella Cheese l) Wolfgang Puck Presents brand Wolfgang Puck Cheese Blend, 100% Natural. Recall #F-815/826-0. CODE None. MANUFACTURER F&A Dairy of California, Inc., Newman, California. RECALLED BY Manufacturer, by telephone, fax, letter on or about August 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION California and Nevada. QUANTITY 447,100 pounds were distributed. REASON Products may contain small pieces of soft plastic. ________ PRODUCT Charley's brand a) Egg Roll; b) Spring Roll with Beef Flavor; c) Spring Roll with Chicken Flavor, 6-ounce and 3-1/2 ounce sizes. Recall #F- 828/830-0. CODE The code reflects the date of manufacture with the number "12" added to each portion of the date. The last date of manufacture for the improperly labeled product produced 7/21/00: (072100) would be 193312. MANUFACTURER Willow Family Foods, Beaverton, Oregon. RECALLED BY Manufacturer, by telephone on July 24, 2000. Firm-initiated field correction (relabeling) complete. DISTRIBUTION Washington state, Oregon, Idaho, Utah, Arizona, Minnesota, Montana. QUANTITY Approximately 300-500 cases per week are distributed. REASON Products contain undeclared FD&C Red No. 40. ________ PRODUCT Darigold Ice Cream in cardboard cartons: a) Very Vanilla b) Summer Strawberry c) Pecan Danish d) Gooey Cluster e) White Chocolate Raspberry f) Black Cherry Chunk Sparkle brand Ice creams in Cardboard cartons: g) Vanilla h) Chocolate. Recall #F-837/844-0. CODE All half gallon ice cream production of April 20, 21, and 22, 2000. 53 21 00111 XX:XX 53 21 00112 XX:XX 53 21 00113 XX:XX The first four digits represent the plant. The 5th through 9th digits are the year and Julian date. The last 4 digits, represented here as XX:XX, are the time code in 24 hour format. All time codes for the three days are affected. Darigold Very Vanilla 53 21 00111, 53 21 00112 Darigold Summer Strawberry 53 21 00111 Darigold Pecan Danish 53 21 00111 Darigold Gooey Cluster 53 21 00111, 53 21 00112 Darigold White Chocolate Raspberry 53 21 00112 Darigold Black Cherry Chunk 53 21 00112 Sparkle Vanilla 53 21 00113 Sparkle Chocolate 53 21 00113 MANUFACTURER West Farm Foods, Seattle Washington. RECALLED BY Manufacturer, by letter on July 28, 2000, and by telephone. Firm-initiated recall complete. DISTRIBUTION Alaska, California, Idaho, Oregon, Washington state. QUANTITY Approximately 7,000 were distributed. REASON Product is unfit for food due to contamination with ammonia. ________ PRODUCT Gourmet Pacific brand tuna in 4-ounce retorted pouches: a) Maui Onion Ahi Tuna; b) Smoked Ahi Tuna. Recall #F-858/859-0. CODE a) 31601-02715-00604; b) 31401-02715-00504. MANUFACTURER Diamond Bay Specialty Seafoods Hawaii, Inc., Kahului, Hawaii. RECALLED BY Manufacturer, by letter on August 5, 2000. Firm-initiated recall ongoing. DISTRIBUTION Hawaii, California, New York, Texas, Washington state, Montana. QUANTITY 2,172 pounds were distributed. REASON Products are decomposed.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT a) Digoxin Injection USP 0.25 mg per ml, 1 ml Tubex cartridge, 10 cartridges per package; 60 cartridges per case, is used to treat heart failure, atrial fibrillation and atrial flutter. NDC #0008-0480-02. b) Dimenhydrinate Injection USP 50 mg per ml, 1 ml Tubex cartridge, 10 cartridges per package; 60 cartridges per case. The product is used to prevent and treat nausea, vomiting, or vertigo related to motion sickness. NDC #0008-0485-01. c) Diphenhydramine HCl Injection USP 50 mg per ml, 1 ml Tubex cartridge, 10 cartridges per package; 60 cartridges per case. The product is used to treat motion sickness and is consider an antihistamine and antiparkinson drug. NDC #0008-0384-01. Recall #D-453/455-0. CODE Lot Numbers: a) 4990194 exp. 5/01; b) 49990197 exp. 10/01; c) Lot 49990052 exp. 2/02. MANUFACTURER Wyeth Ayerst Laboratories, Marietta, Pennsylvania. RECALLED BY Manufacturer, by letter on July 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY a) 40,470 tubexes; b) 70,370 tubexes; c) 40,900 tubexes were distributed. REASON Tubex(r) cartridges may be cracked or chipped. ________ PRODUCT Cephradine Capsules, USP, 500 mg, in 100-count bottles, Rx indicated in the treatment of respiratory tract infections, otitis media, skin and skin- structure infections, and urinary tract infections. NDC #0093-3155-01. Recall #D-460-0. CODE Lot Numbers 57450 EXP 9/00 and 57988 EXP 6/01. MANUFACTURER Teva Pharmaceuticals USA, Fairfield, New Jersey. RECALLED BY Teva Pharmaceuticals USA, Sellersville, Pennsylvania, by letter on August 30, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 10,244 units of lot 057450 and 1,755 units of lot 057988 were distributed; firm estimated that 5 percent of product remained on market at time of recall initiation. REASON Subpotency (stability). ________ PRODUCT Nitroglycerin Sublingual Tablets, 0.4 mg, in 25 and 100-count amber glass bottles. Recall #D-461-0. CODE N419R1 (25 tablets each) NDC 60951-718-25 N419W1 (25 tablets each) NDC 60951-718-25 N459W1 (100 tablets each) NDC 60951-718-70. MANUFACTURER Konec Limited Liability Company, Tucson, Arizona. RECALLED BY Manufacturer, by telephone on or about February 13, 2000. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY N419R1: 8,891 bottles of 25 tablets each N419W1: 16,726 bottles of 25 tablets each N459W1: 4,719 bottles of 100 tablets each. REASON Metal particle contamination. ________ PRODUCT Target Non-Aspirin Pain Reliever Tablets, in 500-count bottles, OTC pain reliever. Recall #D-462-0. CODE Lot #8N00527 EXP 11/01. MANUFACTURER Leiner Health Products, Inc., Kalamazoo, Michigan. RECALLED BY Lenier Health Products, Inc., Carson, California, by letter on August 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION Minnesota, Arizona, California, Colorado, Georgia, Wisconsin, Oregon, Indiana, Virginia, Texas. QUANTITY 400 cases (6 bottles per case) were distributed; firm estimates none remains on the market. REASON Product mix-up - Presence of buffered aspirin (325 mg) in some bottles. ________ PRODUCT Augmentin(r) Oral Suspension (Amoxicillin 400mg/Clavulanate Potassium 57 mg), 400 mg/5mL, in 100 mL multi-dose bottles. PAR NDC #49884-469-05. Recall #D-465-0. CODE Lot #MR2754 EXP 2/01. MANUFACTURER SmithKline Beecham Pharmaceuticals, Bristol, Tennessee. RECALLED BY SmithKline Beecham Pharmaceuticals, NA Philadelphia, Pennsylvania, by letter August 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 59,940 units were distributed. REASON Subpotency of Clavulanic Acid (9 month stability station). ________ PRODUCT Leucovorin Calcium Injection, USP, 500mg/50ml single dose vial, Rx drug product in an amber glass vial. Recall #D-467-0. CODE LOT #99K202 EXP 08/2001. MANUFACTURER Gensia Sicor Pharmaceuticals, Inc., Irvine, California, by letter on August 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Wisconsin, West Virginia, District of Columbia. QUANTITY 13,132 vials were distributed. REASON Particulates (stability).RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Vicodin(r) Tablets (Hydrocodone bitartrate 5 mg and Acetaminophen 500 mg), in 500 count bottles, Rx indicated for the relief of moderate to moderately severe pain. Recall #D-456-0. CODE NDC Number Lot Number EXP Date Bottle Size 0044-0727-03 1076-0418 09/2002 500 count 0044-0727-03 1076-0428 09/2002 500 count 0044-0727-03 1076-0438 09/2002 500 count. MANUFACTURER Knoll Pharmaceutical Company, Whippany, New Jersey. RECALLED BY Knoll Pharmaceutical Company, Mount Olive, New Jersey, by letter on August 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 8,222 bottles were distributed; firm estimates none remains on the market. REASON Dissolution failure. ________ PRODUCT Tri-Nasal (Triamcinolone acetonide, USP) Nasal Spray, 50 mcg, 15 mL, 120 metered sprays, Rx indicated for the treatment of nasal symptoms of seasonal and perennial allergic rhinitis in adults and children older than 12 years of age. NDC #0451-5050-15. Recall #D-458-0. CODE Lot Numbers: 00305 EXP 11/01, 00306 EXP 12/01, 00105, 00205, 00406 and 00506, all EXP 11/02 (physician samples). MANUFACTURER Muro Pharmaceutical, Inc., Tewksbury, Massachusetts. RECALLED BY Manufacturer, by letter on August 29, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 134,138 units were distributed. REASON Leaking containers. ________ PRODUCT Leukeran(r) (chlorambucil) Tablets, 2 mg, in 50-count bottles, Rx. NDC 0173-0635-35. Recall #D-459-0. CODE Lot 0A1387 MANUFACTURER Glaxo Wellcome, Inc., Zebulon, North Carolina. RECALLED BY Manufacturer, by letter on August 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 36,463 units were distributed. REASON Impurity specification failure (stability). ________ PRODUCT Levsinex(tm) Capsules (Hyoscyamine Sulfate, USP), 0/375 mg, Timecap Extended Release, Rx for use as adjunctive therapy in the treatment of peptic ulcer. NDC #0091-3537-01. Recall #D-464-0. CODE Lot #02580K EXP 2002. MANUFACTURER Schwarz Pharma, Seymour, Indiana. RECALLED BY Med-Pro, Inc., Lexington, Nebraska, by telephone on August 11, 2000, and by letter dated August 15, 2000. Firm-initiated recall ongoing. DISTRIBUTION New York. QUANTITY 299 bottles were distributed. REASON Insert incorrectly states product has a clear capsule body and contains beadlets, product actually has a white capsule body and contains a tablet ________ PRODUCT Methocarbamol, USP, bulk active ingredient powder, Rx formulated to produce a muscle relaxant. NDC #0500-1900-57. Recall #D-466-0. CODE Lot Numbers: 00952 and 00949. MANUFACTURER Boehringer Ingelheim Chemicals, Inc., Petersburg, Virginia. RECALLED BY Manufacturer, by telephone on August 18, 2000, and by letters on August 22 and 29, 2000. Firm-initiated recall ongoing. DISTRIBUTION Canada. QUANTITY 2,124.7 kg of product was distributed. REASON Contamination with polypropylene fibers. ________ PRODUCT DesOwen(r) Cream (Desonide Cream), 0.05%, 60g tube. Recall #D-463-0. CODE Lot # PGCN. MANUFACTURER DPT Laboratories, Inc., San Antonio, Texas. RECALLED BY Galderma Laboratories LP, Fort Worth, Texas, by letter on August 9, 2000, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 4,920 units in 410 shipping containers were distributed. REASON Mislabeling - Shipping cases were incorrectly labeled as containing ointment not cream form of product. ________ PRODUCT Aluminum Hydroxide Gel, USP, Antacid, 320 mg/5mL, mint flavor, in 12 and 16-fluid ounce bottles. Recall #D-468-0. CODE Lot Numbers: 9I13 and 9I11. MANUFACTURER Pharmaceutical Associates, Inc., Greenville, South Carolina. RECALLED BY Manufacturer, by letter on February 28, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 6,000 16-ounce and 8,359 12-ounce bottles were distributed. REASON Resuspension problems.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT a) Whole Blood; b) Red Blood Cells; c) Red Blood Cells Leukocytes Reduced; d) e) Platelets; f) Platelets Pheresis; g) Plasma; h) Plasma Pheresis; i) Cryoprecipitated AHF; j) Platelets for Manufacturing Non-Injectable Products; k) Red Blood Cells for Manufacturing Non-Injectables; l) Source Leukocytes; m) Recovered Plasma for Manufacturing Non- Injectables; n) Red Blood Cells for Manufacturing; o) Recovered Plasma. Recall #B-164/177-0. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER American National Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letters dated March 16, 1999, and April 16, 1999, and by fax on March 22, 1999. Firm-initiated recall ongoing. DISTRIBUTION Illinois, Michigan, New Jersey, Ohio, Pennsylvania, California, Switzerland. QUANTITY a) 15 units; b) 307 units; c) 10 units; d) 186 units; e) 18 units; f) 122 units; g) 15 units; h) 35 units; i) 15 units; j) 8 units; k) 6 units; l) 7 units; m) 19 units; n) 217 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from donors who previously tested repeatedly reactive for the antibody, Western Blot indeterminate. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1170/1171-0. CODE Unit #04H86512. MANUFACTURER American Red Cross, Dedham, Massachusetts. RECALLED BY Manufacturer, by letter dated January 19, 2000. Firm-initiated recall complete DISTRIBUTION Massachusetts and Puerto Rico. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had traveled to a malarial endemic area. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1174/1175-0. CODE Unit #38L49351. MANUFACTURER American Red Cross, Fort Wayne, Indiana. RECALLED BY Manufacturer, by telephone or letter on September 1, 1999. Firm- initiated recall complete. DISTRIBUTION Indiana and New York. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had viral hepatitis after age eleven. ________ PRODUCT Platelets. Recall #B-1176-0. CODE Unit #38K90067. MANUFACTURER American Red Cross, Fort Wayne, Indiana. RECALLED BY Manufacturer, by telephone on October 1, 1999. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor in which arm preparation was not performed or was performed inappropriately. _______ UPDATE Southwest Tissue Services, Inc. (SWTSI), San Antonio, Texas recall of Various Human Tissues for Transplant which appeared in the November 25, 1998 Enforcement Report should read Recall #B-157-9.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Cleaning Brush (BW-9Y) for the Olympus SIF-Q140 Video Enteroscope, used for cleaning the endoscope's distal end when inserted through the suction channel (S-cylinder). Recall #Z-912-0. CODE Brush Part # BW-9Y. Serial Numbers of SIF-Q140 enterescopes: 2900008, 2900009, 2900010, 2900011, 2900012, 2900013, 2900036, 2900040, 2900041, 2900042, 2900043, 2900044, 2900045, 2900046, 2900047, 2900048, 2900049, 2900053, 2900054, 2900055, 2900056, 2900057, 2900058, 2900059, 2900060, 2900061. MANUFACTURER Olympus Opto-Electronics, Ltd. - Aizu Factory, Fukushima-Ken, Japan. RECALLED BY Olympus America, Inc., Melville, New York, by letter dated October 12, 1999. Firm-initiated field correction complete. DISTRIBUTION Florida, Oregon, Pennsylvania, Louisiana, New York. QUANTITY 5 units were distributed. REASON Manufacturing defect - cleaning brush too short. ________ PRODUCT a) 6 French Disposable Angiographic Catheters; b) 6 French Special Catheters. Recall #Z-915/916-0. CODE Model Numbers: a) SPC-464D; SPC-464E, SPC 464F; b) SSD-694, SSD-790; SSD-937. MANUFACTURER Millar Instruments, Inc., Houston, Texas. RECALLED BY Manufacturer, by letter dated April 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, France, United Kingdom, Switzerland, Japan, Norway, Germany. QUANTITY PC-464D: 1072 units, SPC-464E: 379 units, SPC-464F: 76 units, SSD-694: 3 units, SSD-937: 1 unit, SSD-790: 0 (none). REASON Presence of small fibers that may shed during use. These catheters were used as components in the Millar devices. ________ PRODUCT Punctur-Gard Revolution Safety Needle Holder, used in conjunction with the Punctur-Guard Blood Collection Needle. Recall #Z-918-0. CODE Reorder Number: 4750 Lot Numbers: K0192, K1391, L2291, L2391, M0291, M0991, M1391, A0701,A2601, B0901, B2901, C1001, C1601, C2301, C2901, C3001, D1801. Shipping cases lot numbers: The number "4750" precedes the lot number, ex: "4750K0192" MANUFACTURER Bio-Plexus, Vernon, Connecticut. RECALLED BY Manufacturer, by letter on May 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Memphis and Tennessee. QUANTITY 14,750 units were distributed. REASON Holder may fail to activate needle safety mechanism. ________ PRODUCT Medtronic 6F SiteSeer Agiographic Catheter, used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessel. Recall #Z-919-0. CODE Catalog #6A0031, Lot #4533. MANUFACTURER Medtronic AVE, Inc., Danvers, Massachusetts. RECALLED BY Medtrtonics Interventional Vascular, Danvers, Massachusetts, by letter on May 16, 2000, and follow-up visit to retrieve product. Firm-initiated recall ongoing. DISTRIBUTION Germany, United Kingdom, Italy, China. QUANTITY 320 units were distributed. REASON Sterility of the device is compromised due to an improperly sealed pouch. ________ PRODUCT Testosterone Reagent Pack, 100 test units per pack, for in-vitro diagnostic use only, intended for the in-vitro quantitative measurement of testosterone in human serum and plasma. Recall #Z-920-0. CODE Lot #20 EXP 6/1/99. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch, Cardiff. RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York, by letters dated May 26, 1999, July 19, 1999, and September 16, 1999. Firm-initiated field correction complete. DISTRIBUTION California, Florida, Indiana, Kentucky, Michigan, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Australia, Canada, Puerto Rico, Panama, Singapore, England, France, Germany, Italy, Spain. QUANTITY 182 packs were distributed. REASON Test results may be identified as ng/mL when results are for ng/dL. ________ PRODUCT Maxxum PTCA Dilation Catheters (Balloon Catheters) Catalog #H74914497300 (20 mm( and Catalog #H74914496300 (13mm), percutaneous transluminal coronary angioplasty catheters used to dilate coronary artery stenoses or previously placed stents. Recall #Z-942/943-0. CODE Lot # 2780769A, Catalog # H74914496300, expiration date: 2001-11; and Lot # 2781099A, Catalog # H74914497300, expiration date: 2001-11. MANUFACTURER Boston Scientific Scimed, Inc., Maple Grove, Minnesota. RECALLED BY Manufacturer, by letter dated June 22, 2000, followed by telephone on or about June 26, 2000. Firm-initiated recall complete. DISTRIBUTION Florida, Indiana, Oklahoma. QUANTITY 8 catheters were distributed. REASON Balloon PTCA Catheters were mislabeled as to length. ________ PRODUCT BE-148-4 Cuff Pressure Monitor. Recall #Z-945-0. CODE PO112599. MANUFACTURER Instrumentation Industries, Inc., Bethel Park, Pennsylvania. RECALLED BY Manufacturer, by telephone on June 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Florida, Louisiana, Maryland, Minnesota, North Carolina, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, West Virginia, Canada. QUANTITY 103 units were distributed. REASON There is a tight fit between small port and mating part (pilot line check valve) which precludes a connection. _______ PRODUCT Incubator 8000 NC/SC/IC (Neotatal Incubator) and Radiant Heater RH600 (Infant Radiant Heater). The heater was sold separately and could have been mounted to the incubator, floor stand or wall. Recall #Z-946/947-0. CODE Drager Incubator 8000 SC/NC/IC catalog numbers: FR00054, 2M21250, 2M21635, 2M21989, 2M220550, 2M21251, 2M21973, 2M220551, 2M21281, and 2M21966. Drager Radiant Heater RH600 catalog number: 2M20116. MANUFACTURER Drager Medizintechnik GmbH (DMT) Lubeck, Germany. RECALLED BY North American Drager, Telford, Pennsylvania, by letters July 2, 2000, and August 28, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 487 units were distributed. REASON The skin temperature sensor for the incubator 8000 is not working properly. ________ PRODUCT Radiolucent Threaded Cannula (5mm X 10mm), an endoscopic device that provides access to the patient's peritoneal cavity and allows insertion of endoscopic instruments and the removal of specimens. Recall #Z-948-0. CODE Catalog #MB319 and/or COE28. MANUFACTURER Applied Medical Resources, Laguna Hills, California. RECALLED BY Aesculap, Inc., South San Francisco, California, by telephone on May 16, 2000, and by letter May 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 68 units were distributed. REASON The device has the potential to crack in the shaft of the cannula over time.RECALLS AND FIELD CORRECTIONS: DEVICES CLASS III
________ PRODUCT TSH Reagent Pack, Catalog #191 2997, intended for the in vitro quantitative measurement of thyroid stimulating hormone in human serum and plasma to aid in the differential diagnosis of thyroid disease. Recall #Z-917-0. CODE Lot #180 EXP 8/29/2000. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch Cardiff. RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York, by letter dated February 23, 2000. Firm-initiated recall complete. DISTRIBUTION Alaska, Alabama, Florida, Indiana, Kentucky, North Dakota, Nebraska, Texas, Washington state. QUANTITY 1,186 packs were distributed. REASON Reagent instability caused negative bias with control and/or patient samples. ________ PRODUCT Tigertail Flexible Tip Ureteral Catheter labeled to contain 6 Fr. Catheters, used to facilitate urinary drainage from the kidney and/or injection of contrast media into the kidney. Recall #Z-938-0. CODE Lot # 07AK0326. MANUFACTURER C.R. Bard, Inc., Queensbury, New York. RECALLED BY C.R. Bard, Inc., Covington, Georgia, by telephone, followed by letter dated February 9, 2000. Firm-initiated recall complete. DISTRIBUTION Arizona, Colorado, Illinois, Missouri, New York, Utah, North Carolina, New Jersey. QUANTITY 89 units were distributed. REASON Package labeled as 6 FR. Catheters, contained 4 Fr. Catheters. ________ PRODUCT Utah Medical Products, Deltran IV-Plus Pressure Monitoring Kit, Catalog No. ABC-448-6. Recall #Z-944-0. CODE Lot #192335-1. MANUFACTURER Utah Medical Products, Inc., Midvale, Utah. RECALLED BY Manufacturer, by letter on July 6, 2000. Firm-initiated recall complete. DISTRIBUTION California, Michigan, Montana, West Virginia. QUANTITY 185 units were distributed. REASON Kits were mislabeled as an obstetric vacuum kit. ________ PRODUCT Abbott AxSYM Estradiol Reagent Pack, List 7A63-20, 10- test kit; an in- vitro diagnostic microparticle enzyme immunoassay (MEIA) for the quantitative determination of estradiol in human serum on the AxSYM System. Recall #Z-950-0. CODE All in date lots: 61221Q100, 61335Q100, 62242Q100, 62357Q100, 63162Q100, 64018Q100, 63259Q100. MANUFACTURER Abbott Health Products, Inc., Barceloneta, Puerto Rico. RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois, by letter dated July 9, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, New Zealand, England, Australia, Dominican Republic, Mexico, Japan, Guatemala, Argentina, Singapore, Bermuda, Peru, Brazil, Korea, Hong Kong, Colombia, Taiwan, Canada, Thailand, Costa Rica, Chile, Pakistan, El Salvador, Curaco, Paraguay, India. QUANTITY 13,675 kits were distributed. REASON Depressed estradiol results when using the undiluted protocol. ________ PRODUCT IMx Estradiol Reagent Pack, List 2215-22, 100-test kit; an in-vitro diagnostic microparticle immunoassay (MEIA) for the quantitative determination of estradiol in human serum or plasma on the IMx Analyzer. Recall #Z-951-0. CODE Lot numbers 58417M300, 63210M100. MANUFACTURER Abbott Laboratories, Inc., Abbott Park, Illinois. RECALLED BY Manufacturer, by letters on July 9, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, British West Indies, England, Australia, Dominican Republic, Mexico, Japan, Guatemala, Argentina, Singapore, Bermuda, Peru, Brazil, Korea, Hong Kong, Colombia, Taiwan, Canada, Thailand, Chile, Pakistan, Jamaica, Venezuela, Panama, Uruguay, Paraguay, West Indies, Antigua, Ecuador, Nicaragua, Turk and Caicos Islands, Bahamas, Honduras, Surinam, Germany, Italy, India. QUANTITY 3,345 kits were distributed. REASON Depressed estradiol results when using the undiluted protocol. ________ PRODUCT Vitros Immunodiagnostic - TSH Reagent Pack, 100 tests per pack, for the in vitro quantitative measurement of thyroid stimulating hormone in human serum and plasma. Recall #Z-952-0. CODE Lot number 340. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch Cardiff. RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York, by letter on June 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada, Australia, India, Japan, Singapore, England, France, Germany, Italy, Spain. QUANTITY Domestic - 208 Packs (includes 10 to OCD); International 373 packs were distributed. REASON Some TSH Reagent packs may contain incorrectly labeled reagent bottles. ________ PRODUCT Medtronic Sigma SDR303 and SS303 Implantable Pulse Generators, used for the restoration of heart rhythm. Recall #Z-979/980-0. CODE Serial numbers PJD622392S, PJD200335S, and PJD100767H, MANUFACTURERS Medtronic Med Rel, Inc., Humacao, Puerto Rico. Switzerland Manufacturing Operations Tolochenaz, Switzerland. RECALLED BY Medtronic, Inc., Minneapolis, Minnesota, by letters dated June 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Puerto Rico, United Kingdom, and Germany. QUANTITY 3 units were distributed. REASON Final device programming does not match the label identification. ________ PRODUCT AcuMatch C-Series Cemented Femoral Component, Size 6 (Originally named the Exactech AuRa Hip System Femoral Component but has been renamed AcuMatch C-Series), hip implant, femoral component-these stems are intended to be used with bone cement for the treatment of skeletally mature individuals undergoing primary surgery for total hip replacement. Recall #Z-986-0. CODE Product #112-01-06, Serial Numbers: 0107189-0107208, 0112411-0112430, 0111635, 0121750-0121768, 0123858-0123861, 0143717-0143740. MANUFACTURER Exactech, Inc., Gainesville, Florida. RECALLED BY Manufacturer, by telephone on May 25, 2000, and by fax on May 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION Florida, South Carolina, Alabama, New York, Louisiana, Pennsylvania, Minnesota, Ohio, New Jersey, Nebraska, Washington state, California, Connecticut, Michigan. QUANTITY 43 units were distributed. REASON Products were mislabeled with the incorrect stem length. ________ PRODUCT Datascope 9.5 Fr. 34 cc True Sheathless Intra-Aortic Balloon Catheter with 10 Fr. 6-inches Sheath, Model #0684-00-0314-01. Recall #Z-1012-0. CODE Lot Numbers: AXD, AYL, ATS, ASC, AUD, AZI. MANUFACTURER Datascope Corporation, Fairfield, New Jersey. RECALLED BY Manufacturer, by letter dated July 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Illinois, Michigan, Connecticut, California, Maryland, Arizona. QUANTITY 169 units were distributed. REASON The outside user label on the product describes the insertion kit as containing a 10 Fr. 11" catheter introducer instead of correctly identifying it as containing a 10 Fr. 6" catheter introducer. ________ PRODUCT Zimmer ZMR Hip System Implant Assembly Guide, Catalog #00-9975-043-00, used to record the orientation of the proximal body and distal stem implant provisionals for later assembly of the final implant components. Recall #Z-1013-0. CODE Lot Numbers: 66806000, 66820900, 66915700, 68180600. MANUFACTURER Zimmer, Inc., Warsaw, Indiana. RECALLED BY Manufacturer, by e-mail and letter on August 15, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Australia, Canada, Germany, Italy, Singapore and United Kingdom. QUANTITY 177 units were distributed between March and June 2000. REASON The product was found adulterated and misbranded, in that the alignment arrow was oriented incorrectly on the component.####
END OF ENFORCEMENT REPORT FOR SEPTEMBER 20, 2000.
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