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FDA RECALLS & COURT ACTIONS: Feb. 26 & March 4, 1992

Executive Summary

CLASS II -- ASPIRIN TABLETS Uncoated, 5 grains, under the following labels: Swan, 100 tablets and 300 tablets; Always Save, 250 tablets; Springfield, 250 tablets; Super Tru, 250 tablets; Target, 300 tablets. Recall number: D-232-2. Lot numbers and EXP dates: 13284 11/96, 13532 12/96 (Swan); 13532-1 12/96 (Always Save); 13530 12/96 (Springfield); 13529 12/96 (Super Tru); 13293 11/96, 13529 12/96, 13531 12/96, 13532 12/96 (Target). Manufacturer: Cumberland-Swan, Inc., Smyrna, Tennessee. Recalled by: Manufacturer, by letter Jan. 22, 1992. Firm-initiated recall ongoing. Distribution: Arkansas, California, Georgia, Massachusetts, Minnesota, Nebraska, New York, Tennessee, Texas, Virginia, Wisconsin. 1,203 cases (144 bottles per case) were distributed. Reason: Possible presence of metal particles. CLASS II -- (a) CHERRY FLAVORED ACETAMINOPHEN ELIXIR; (b) GRAPE FLAVORED ELIXIR (a) Under the Rugby, Treasury, Pick N' Save Drugs, Taylor, True Quality, Medi Save, and Health Center labels; (b) under the Rugby, NP, Treasury, Pick N' Save Drugs and Drug Guild labels, in 4 fluid ounce containers. Recall number: D-224-2. Lot numbers: (a) L112013, L004023-1, L011010-2, 002022-3, L102054-1, L104007-3, L109012-1, L110015-2, L112014-1, L007007-1, 003059, L106047-1, L112014-3, L010009-2, L004023-2, L105067-2, L104007-1, L106074-1, L109012-4, L111051, L112014-4, L011010-1, L004023-2, L101048-1, L104007-2, L106074-2, L110015-1, L101054-2, L1104007-4, L109012-2, L110015-3, L112014-2, L010009-1, 003084, L105067-1, L102054-3, L105039, L109012-3, L007008-1; (b) L110089-1, L108064-5, L005038, L108064-1, L004011, L108064-2, L102038-1, L108064-3, L012038-2, L108064-4, L012038-3, L11089-2 (grape). Manufacturer: Naska Pharmacal Company, Inc., Lincolnton, North Carolina. Recalled by: Manufacturer, by letter on or about Jan. 8, 1992. Firm-initiated recall ongoing. Distribution: (a) Texas, Alabama, Louisiana, Tennessee, Kentucky; (b) Pennsylvania, Louisiana, Florida (grape). (a) 282,341 units; (b) 65,361 units were distributed. Reason: Markings on dosage cup not totally compatible with label dosage instructions. CLASS II -- CODEINE ANTITUSSIVE COUGH SYRUP 10 mg/5 ml, packaged in 4 fluid ounce glass bottles, OTC, oral administration for temporary relief of coughs due to common cold, under the following labels: Saverex Drugs, Pawleys Island Apothecary, Rushville Pharmacy, 101 Pharmacy, Arlington Rexall Drugs, Ridgemont Drugs, NJ/Hillsdale Pharmacy, The Prescription Center, Wasem's Rexall Drugs, James Discount Drugs, Corner Drug Store, Shelton's Pharmacy, Family Pharmacy of Collierville, Inc., Eastgate Pharmacy, Dan Purvis Drugs, White Way Pharmacy, Bill's Pharmacy, McLeskey-Todd Drug Co., Savage's Drug Store. Recall number: D-233-2. Code C-V26, EXP 10/95. Manufacturer: Weeks & Leo Company, Inc., Des Moines, Iowa. Recalled by: Manufacturer, by telephone Dec. 5, 1991. Firm-initiated recall ongoing. Distribution: South Carolina, Mississippi, Tennessee, Washington state, Indiana, New Jersey, Virginia. 792 bottles were distributed. Reason: Product label fails to bear pregnancy/nursing warning statement and a statement indicating the type of tamper-resistant packaging. CLASS II -- FENOPREN CALCIUM CAPSULES AND TABLETS (a) 200 mg; (b) 300 mg; (c) 600 mg, a Rx drug used for the relief of signs and symptoms of rheumatoid and osteo-arthritis, under the Blue Cross, Parmed, Schein, Rugby, and Genetco labels. Recall number: D- 227/229-2. Lot numbers: 9L29N, 0D20C, 1G24G, 1K11; (b) 9L02, 9L29M, 0D09L, 0E16B, 0K16E, 1629, 1H21, 1K22C; (c) 9L06G, 9L22E, 0E17K. Manufacturer: Halsey Drug Company, Inc., Brooklyn, New York. Recalled by: Manufacturer, by letter Feb. 11, 1992. Firm-initiated recall ongoing. Distribution: Unknown. 3,500,000 capsules and 150,000 tablets were distributed. Reason: Source of raw material active ingredient cannot be verified. Lot 0D09L also failed dissolution specifications. CLASS II -- FOUGERA ERYTHROMYCIN OPHTHALMIC OINTMENT USP Sterile, 1 gram unit dose. Recall number: D-230-2. All lots within expiration dates. Lot numbers as follows: 0092, 0257, 0467, 0521, 0574, 0522, 0575, 0749, 0796, 0797, 1063, 1095, 1202, 1286, 1478, 1528, 1723, 1955, 1957, 2007, 2036, 2037, 2068, 2204. Manufacturer: Fougera Division of Altana, Inc., Melville, New York. Recalled by: Manufacturer, by letter Feb. 13, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. Approximately 493,500 to 701,800 units were distributed. Reason: When opening the container, the plastic tip closure may be pushed into tube resulting in potential for plastic tip to be instilled in patient's eye. CLASS II -- FOUGERA PURALUBE PETROLATUM OPHTHALMIC OINTMENT A sterile-ocular lubricant, 1 gram unit dose. Recall number: D-231- 2. Lot numbers 0283, 1540. Manufacturer: Fougera Division of Atlanta, Inc., Melville, New York. Recalled by: Manufacturer, by letter Feb. 13, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. Approximately 15,000 units were distributed. Reason: When opening the container, the plastic tip closure may be pushed into tube resulting in potential for plastic tip to be instilled in patient's eye. CLASS II -- LEVOTHROID (LEVOTHYROXIN SODIUM, USP) TABLETS 100 mcg, in 100 tablet bottles, a Rx product used as a replacement for substitution therapy for diminished or absent thyroid function. Recall number: D-216-2. Code: 05428-1 EXP 4/93. Manufacturer: Pharmacy Dispensing Quantities, Inc., Fort Scott, Kansas (repacker/responsible firm). Recalled by: Repacker, by letter Dec. 23, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. 1,498 bottles were distributed. Reason: An Inderal 10 mg tablet was found in a bottle of the product. CLASS II -- LYPHOMED BRAND NITROGLYCERIN INJECTION, USP 5 mg/ml, in 5 ml and 10 ml vials, a Rx injectable for intravenous infusion after dilution for control of blood pressure during surgical procedures. Recall number: D-214-2. Lot numbers: 110359 EXP 10/92 (5 ml), 110367 EXP 10/92 (10 ml). Manufacturer: Lyphomed, Division of Fujisawa USA, Inc., Melrose Park, Illinois. Recalled by: Manufacturer, by letter Feb. 7, 1992. Firm-initiated recall ongoing. Distribution: Florida, New York, California, New Jersey, Puerto Rico, India. 24,250 5-ml vials and 15,720 10-ml vials were distributed; firm estimates none remains on the market. Reason: Subpotency. CLASS II -- (a) LYPHOMED SODIUM CHLORIDE INJECTION, USP; (b) BACTERIOSTATIC SODIUM CHLORIDE INJECTION, USP (a) Concentrated 23.4% 4 mEq/ml, must be diluted prior to IV administration, preservative free, in 30 ml single dose vial; (b) 0.9% not for use in newborns, for drug diluent use only, in 30 ml multiple dose vials. Recall number: D-234/235-2. Lot numbers: (a) 311159, 311160, 311183, 311184, 311206, 311291; (b) 311262, 311263. Manufacturer: Lyphomed, Division of Fujisawa USA, Inc., Grand Island, New York. Recalled by: Lyphomed, Division of Fujisawa USA, Inc., Melrose Park, Illinois, by telephone Feb. 21, 1992, followed by letter Feb. 24, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. (a) 171,525 units; (b) 23,775 units were distributed; firm estimates very little, if any, of either product remains on the market. Reason: The phrases "Concentrated" and "Must Be Diluted prior to I.V. Administration" for the 23.4% product and the phrase "Not for Use in Newborns" for the 0.9% product did not appear in bold red letters as intended. CLASS II -- OTC ACETAMINOPHEN LIQUID Cherry and grape flavors, in 4 fluid ounce plastic bottles, with accompanying dosage cup, indicated for relief of children's fever and pain, under the K.C. Pharmaceuticals, Leiner Nutritional Products, and Topco Associates labels. Recall number: D-219-2. Lot numbers 9B21401, 9C21402, 9F21403, 9F21404, 0A025, 0E048, 0K018, 0M016, 0N029, 1D033, 1D035, EXP dates range from 3/91 to 11/92. Manufacturer: K.C. Pharmaceuticals, Inc., Pomona, California. Recalled by: Manufacturer, by letter Jan. 10, 1992. Firm-initiated recall ongoing. Distribution: California, Illinois. 81,822 bottles were distributed; FDA estimates 8,000 bottles remain on the market. Reason: Markings on dosage cup not totally compatible with label dosage instructions. CLASS II -- OTC ORAL LIQUID MEDICATIONS FOR PEDIATRICS Packed with plastic dose cups: (a) Gold Banner Children's No-Aspirin Acetaminophen Elixir, Grape Flavored Liquid, Alcohol Free, Saccharin Free; acetaminophen 80 mg/2.5 ml; distributed by: Nutrition Research Labs., Inc., 4 fluid ounce bottle with measured dosage cup with teaspoon, tablespoon and fluid ounce increments and "DC100" and "KF19" embossed on the bottom of the cup; (b) Walgreen's Children's Cough & Cold Formula, alcohol free, saccharin free liquid; each 5 ml contains pseudoephedrine hydrochloride 15 mg, chlorpheniramine maleate 1 mg and dextromethorphan hydrobromide 5 mg; nasal decongestant for stuffy noses, antihistamine for runny noses, cough suppressant for coughs; distributed by: Walgreen Co., 4 fluid ounce bottle with measured dosage cup with teaspoon, dessertspoon, tablespoon, dram, fluid ounce, cc and ml increments and "A 6" embossed on the bottom of the cup. Recall number: D-236/237-2. Lot numbers: (a) ORBD and ONXO; (b) 1XCS, 1G1283 and 1I1201. Manufacturer: Xcel Laboratories, Inc., Chicago, Illinois. Recalled by: Xcel Laboratories, Inc., Elmhurst, Illinois, by letter Feb. 19, 1992. Firm-initiated recall ongoing. Distribution: (a) Florida, Illinois, Connecticut, Minnesota; (b) Arizona, Texas, Illinois, Florida, Wisconsin, Tennessee. (a) 3,336 bottles; (b) 45,000 bottles were distributed; firm estimates 7,500 units remain on the market. Reason: Markings on dosage cup not totally compatible with label dosage instructions. CLASS II -- PHERAZINE PLAIN SYRUP (PROMETHAZINE HCL SYRUP) 6.25 mg/5 ml, in 4 ounce, 16 ounce and 1 gallon bottles, a Rx drug prescribed for allergies and allergic reactions, under the Blue Cross, Rugby, Schein, Major Pharmaceuticals and Qualitest labels. Recall number: D-226-2. Lot numbers: 44960, 44995, 45013, 45066, 45073, 45085, 45128, 45196. Manufacturer: Halsey Drug Company, Inc., Brooklyn, New York. Recalled by: Manufacturer, by letter dated Feb. 3, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. 7,500 gallons were distributed. Reason: Product marketed without an Abbreviated New Drug Application approval. CLASS III -- CHLOR-TRIMETON BRAND OF CHLORPHENIRAMINE MALEATE 8 mg, sustained release allergy relief coated tablets, 48 tablets per box (2 blister packs of 24 tablets per box). Recall number: D- 239-2. Lot numbers: 1-CC-5 EXP 3/96, 0-CC-108 EXP 10/96. Manufacturer: Schering Corporation, Kenilworth, New Jersey. Recalled by: Schering-Plough Healthcare Products, Inc., Memphis, Tennessee, by telephone Jan. 15, 1992, followed by letter Jan. 17, 1992. Firm- initiated recall ongoing. Distribution: Nationwide. 3,062 dozen were distributed. Reason: The label fails to bear directions for use. CLASS III -- CLONIDINE HCL TABLETS 0.3 mg, in 100 tablet bottles, a Rx drug indicated for the treatment of hypertension, under the Best label only. Recall number: D-218-2. Lot numbers 322991 EXP 8/93, 127491 EXP 9/93. Manufacturer: Par Pharmaceutical, Inc., Spring Valley, New York. Recalled by: Manufacturer. Firm-initiated recall ongoing. Distribution: Florida. 72 bottles were distributed. Reason: Correct tablet number 112 was misprinted as 110 on the side panel of the Best brand label. CLASS III -- (a) POLYCILLIN-N (STERILE AMPICILLIN SODIUM, USP); (b) ADD-VANTAGE VIAL POLYCILLIN-N (STERILE AMPICILLIN SODIUM, USP) (a) For I.M. or I.V. use, equivalent to 125 mg ampicillin, a Rx drug used in the treatment of infections caused by susceptible strains of the designated organisms, under the Bristol Laboratories label; (b) for I.V. use equivalent to 125 mg ampicillin, a Rx drug under the Bristol Laboratories and VHA Plus labels. Recall number: D-220/221- 2. Lot numbers and EXP dates: (a) E8444B 05/92, E8444E 05/92, G8V84B 07/92, L9V63A 11/93, M9V38A 11/93, B0W14B 01/94, D0V56C 03/94, E0V06A 03/94, F0V76A 05/94, H0V25B 08/94, L0V85A 10/94, E8444D 05/92, E8444F 05/92, J8V28B 09/92, M9V37A 11/93, M9V39A 11/93, D0V56B 03/94, D0V86B 04/94, E0V52A 04/94, F0V94A 06/94, L0V76A 11/94; (b) B0V69A 12/93, B0V70C 01/94, BIV38A 02/95, B0V70A 01/94, B0V71B 01/94 (Add-Vantage vial); E8444A 05/92, E0V52B 04/94, H0V25A 08/94, C0W46A 03/94, F0V76B 05/94 (VHA Plus label). Manufacturer: Bristol-Myers Squibb Company, Barceloneta, Puerto Rico. Recalled by: Apothecon, a Bristol-Myers Squibb Company, New Brunswick, New Jersey, by letter Sept. 20, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. (a) 17,499,182 vials; (b) 242,352 vials (VHA Plus); 1,440 vials (Add-Vantage) were distributed. Reason: Some lots exceed moisture specification. CLASS III -- RITE-AID EXTRA STRENGTH COUGH FORMULA In 8 ounce bottles. Recall number: D-225-2. Lot number 106-868. Manufacturer: Hi Tech Pharmacal Company, Inc., Amityville, New York. Recalled by: Manufacturer, by letter Dec. 8, 1991. Firm-initiated recall ongoing. Distribution: Pennsylvania. 3,444 bottles were distributed. Reason: The label erroneously bears the word "Expectorant." CLASS III -- Rx TYLENOL WITH CODEINE No. 3 TABLETS In 100 tablet bottles. Recall number: D-215-2. Lot number HC1632P EXP 3/94. Manufacturer: McNeil Pharmaceutical Company, Dorado, Puerto Rico. Recalled by: McNeil Pharmaceutical, Spring House, Pennsylvania, by letter Jan. 20, 1992. Firm-initiated recall ongoing. Distribution: New York, Pennsylvania, Florida, Virginia, Maryland, Georgia, Alabama, West Virginia, South Carolina, Rhode Island, Connecticut, North Carolina, Maine, Vermont. 13,680 bottles were distributed; firm estimates 1,000 bottles remain on the market. Reason: Some bottles in correctly labeled unit cartons were placed in a packer labeled Tylenol with Codeine No. 2 tablets. The outer shipping carton is correctly labeled. CLASS III -- SULFAMETHOXAZOLE/TRIMETHOPRIM TABLETS, USP 800 mg/160 mg, a Rx synthetic antibacterial combination drug for the treatment of various internal infections. Recall number: D-238-2. Lot number 18095 EXP 93/09/30. Manufacturer: Rx Services, Inc., Ridgeland, Mississippi (repacker/responsible firm). Recalled by: Repacker, by telephone Jan. 23, 1992. Firm-initiated recall ongoing. Distribution: Mississippi. 20 vials were distributed; firm estimates none remains on the market. Reason: Repacked label declares ingredients as "160 mg/800 mg" instead of "800 mg/160 mg. CLASS III -- TRANDATE (LABETALOL HYDROCHLORIDE) TABLETS 100 mg, in 100 tablet bottles, a Rx drug for use in the management of hypertension. Recall number: D-217-2. Code: Z60300MX EXP MAY94. Manufacturer: Pharmacy Dispensing Quantities, Inc., Ft. Scott, Kansas (repacker/responsible firm). Recalled by: Repacker, by letter Aug. 13, 1991. Firm-initiated recall complete. Distribution: New York, Missouri, Tennessee, South Dakota, Idaho, Ohio, Pennsylvania, Indiana. 140 bottles were distributed. Reason: The label correctly declares the product as 100 mg but the ingredient statement shows the product as 200 mg. CLASS III -- (a) XYLOCAINE (LIDOCAINE HCL) SOLUTION; (b) METHYLPARABEN FREE XYLOCAINE-MPF (LIDOCAINE HCL) INJECTION (a) 1%, 10 mg/ml with epinephrine 1:200,000, a Rx parenteral drug intended for major nerve block including epidural, in 5 ml single dose vials; (b) 1%, 10 mg/ml, with epinephrine 1:200,000, a Rx parenteral drug intended for major nerve block including caudal and epidural use, in 5 ml single dose vials. Recall number: D-222/223-2. Lot numbers: (a) 001081 EXP 1/92; (b) 003147 EXP 3/92. Manufacturer: Astra Pharmaceutical Products, Inc., Westborough, Massachusetts. Recalled by: Manufacturer, by letter Dec. 12, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. (a) 903 master cartons each containing 10 5-ml single dose vials; (b) 1,865 master cartons each containing 10 5-ml single dose vials were distributed. Reason: Subpotent for epinephrine ingredient or potency of epinephrine ingredient not assured through expiration date.

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