FDA RECALLS & COURT ACTIONS: Dec. 18 & 26, 1991

CLASS II -- ALLOPURINOL TABLETS 300 mg, in 500 and 100 tablet bottles, an oral Rx uricosuric (increase urinary excretion), under Barr, Major, and UDL labels. Recall number: D-125-2. Barr lot numbers: IB242FS EXP 4/94, OH242AO EXP 8/93, 1B242FS EXP 4/94, OK242AX EXP 11/93; Major lot number IB242FS EXP 4/94; UDL Lot number OPO 77. Manufacturer: Barr Laboratories, Inc., Northvale, New Jersey. Recalled by: Barr Laboratories, Inc., Pomona, New York, by letters of Sept. 30, 1991 and Oct. 30, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. 2,020 bottles of 500 tablets from lot number OH242AO, 14,571 bottles of 100 from lot IB242FS, 2,918 bottles from lot OK242AX, and 2,879 bottles from lot 1B242FR were distributed. Reason: Product fails dissolution testing. CLASS II -- ALLOPURINOL TABLETS, USP 300 mg, in unit dose packaged 10 tablets per strip, 10 strips per carton, an Rx oral medication used to reduce serum and urinary uric acid concentrations in the management of primary and secondary gout. Recall number: D-131-2. Lot number OPO77 EXP 10/92. Manufacturer: Barr Laboratories, Inc., Northvale, New Jersey. Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by letters of Oct. 2, 1991 and Dec. 4, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. 4,535 cartons were distributed; firm estimates 1,300 cartons remain on the market. Reason: Product fails dissolution testing. CLASS II -- (a) FLUCINOLONE ACETONIDE TOPICAL CREAM; (b) FLUOCINOLONE ACETONIDE TOPICAL CREAM (a) 0.01%; (b) 0.25%. Recall number: D-106/107-2. Lot numbers: (a) 8289; (b) 9518. Manufacturer: Pharmafair, Inc., Hauppague, New York. Recalled by: Manufacturer, by letter Sept. 23, 1991. Firm-initiated recall ongoing. Distribution: Connecticut, Washington, North Carolina, California, Texas. (a) 677 units; (b) 849 units were distributed. Reason: Subpotency. CLASS II -- (a) PILOCARPINE HCl SOLUTION; (b) SODIUM CHLORIDE SOLUTION; (c) POLYVINYL ALCOHOL; (d) HYDROXYPROPLYMETHYL CELLULOSE SOLUTION; (e) NEOMYCIN AND POLYMIXIN B SULFATES AND HYDROCORTISONE OTIC SOLUTION; (f) NEOMYCIN AND POLYMIXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION (a) 4%, sterile Rx ophthalmic used to manage intraocular pressure in glaucoma, in 15 ml bottles; (b) 5%, OTC for use in temporary relief of corneal edema, in 15 ml and 30 ml bottles; (c) 1.4%, OTC for the temporary relief of burning and irritation due to dryness of the eye, in 15 ml bottles; (d) 2.5%, OTC for professional use in Gonicoscopic examination, in 15 ml bottles; (e) USP, a Rx antibacterial and anti-inflammatory solution for otic use, in 10 ml bottles; (f) a Rx sterile antimicrobial/anti-inflammatory suspension formulated for otic use, in 10 ml bottles. Recall number: D-109/114- 2. Lot numbers: (a) 0320 EXP 5/94, 0352 EXP 5/94; (b) 0315 EXP 5/95, 0360 EXP 5/95, 0387 EXP 6/95; (c) 0325 EXP 11/93; (d) 0363 EXP 6/93; (e) 0381 EXP 6/94, 0394 EXP 6/94; (f) 0201 EXP 8/93. Manufacturer: Pharmafair, Inc., Hauppauge, New York. Recalled by: Manufacturer, by letter Oct. 30, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. (a) 60,000 units; (b) 74,000 units; (c) 30,000 units; (d) 15,000 units; (e) 86,000 units; (f) 42,000 units were distributed. Reason: Lack of assurance of sterility. CLASS II -- UNIT DOSE PACKAGED ORAL Rx DRUGS Packaged and distributed by UDL Laboratories, 10 unit dose tablets per strip, 10 strips per carton: Benztropine Mesylate Tablets, USP, used in the treatment of Parkinsonism (a) 0.5 mg; (b) 1 mg; (c) 2 mg; (d) Hydrocodone Bitartrate and Acetaminophen Tablets, 5 mg/500 mg, a schedule III narcotic used for the relief of moderate to moderately severe pain (5 cards of 20 unit dose tablets per carton); (e) Oxybutynin Chloride Tablets, USP, 5 mg, used for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder. Recall number: D-126/130-2. Lot numbers: (a) 0K584 EXP 2/92, 0M881 3/92, 0V246 EXP 10/92; (b) 0K862 EXP 2/92, 0M893 EXP 3/92, 0S179 EXP 7/92, 0S181 EXP 8/92; (c) 0K870 EXP 2/92, 0M877 EXP 3/92, 0M905 EXP 3/92, 0V195 EXP 8/92, 1A347 EXP 8/92, 1B395 EXP 8/92; (d) 0I534 EXP 2/92, 0J728 EXP 4/92, 0K839 EXP 7/92, 0V192 EXP 10/92, 0C246 EXP 1/92, 0C303 EXP 2/92, 0C312 EXP 2/29, 0H479 EXP 4/92, OH482 EXP 4/92, 0J714 EXP 5/92, 0J720 EXP 5/92, 0M880 EXP 5/92, 0M891 EXP 7/92, 0S119 EXP 10/92, 1A266 EXP 8/92, 1A272 EXP 10/92, 1C458 EXP 10/92, 0A076 EXP 1/92; (e) 0C306 EXP 1/92, 0I524 EXP 3/92, 0K778 EXP 7/92, 0P064 EXP 9/92, 1B380 EXP 10/92. Manufacturer: Pharamaceutical Basics, Inc (PBI), Denver, Colorado. Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by letter Nov. 19, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. (a) 10,384 unit cartons; (b) 57,016 unit cartons; (c) 42,925 unit cartons; (d) 32,055 unit cartons; (e) 66,456 unit cartons were distributed; firm estimates 35 percent remains on the market. Reason: Lack of assurance of bioequivalency and Abbreviated New Drug Application discrepancies. CLASS III -- BARRE DRUG BRAND GENTIAN VIOLET In 30 ml units, an OTC product. Recall number: D-117-2. Lot number 91583 EXP 5/93. Manufacturer: Cumberland-Swan, Inc., Smyrna, Tennessee. Recalled by: Barre-National, Inc., Baltimore, Maryland, by letter Oct. 25, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. 10,728 units were distributed; firm estimates none remains on the market. Reason: Superpotency. CLASS III -- BAUSCH & LOMB BRAND ACETIC ACID 2% ALUMINUM ACETATE (BOROFAIR) STERILE OTIC SOLUTION USP In 60 ml vials, a Rx product indicated for use in the treatment of superficial infections. Recall number: D-123-2. Lot number 0515 EXP 10/93. Manufacturer: Pharmafair, Inc., Hauppauge, New York. Recalled by: Manufacturer, by letter Nov. 11, 1991. Firm-initiated recall ongoing. Distribution: Ohio, New Jersey, California, Louisiana, Kentucky, Connecticut, Texas, Washington state, New York, Pennsylvania, Maryland, Hawaii, South Carolina, Florida, Indiana, Michigan, Wisconsin. Approximately 16,667 vials were distributed. Reason: Label does not declare the boric acid ingredient. CLASS III -- BAUSCH & LOMB BRAND ACETIC ACID 2% AND ALUMINUM ACETATE OTIC SOLUTION, USP Sterile, a Rx drug for the treatment of superficial infections of the external auditory canal. Recall number: D-108-2. Lot numbers: 0106 7/93, 0203 9/93, 7798 11/91, 7803 11/91, 8144 3/92, 8204 4/92, 8205 4/92, 8266 4/92, 8273 5/92, 8348 5/92, 9852 2/93, 9993 5/93. Manufacturer: Pharmafair, Inc., Hauppauge, New York. Recall by: Manufacturer, by letter Oct. 30, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. 150,000 units were distributed. Reason: Aluminum acetate ingredient is subpotent. CLASS III -- CALAMINE LOTION In 4 ounce bottles, an OTC product available in lotion form, applied topically to dry the oozing and weeping of poison ivy, oak, and sumac, under Barre-National, Major, Quality, Valumed, and Revco labels. Recall number: D-115-2. Lot number 03680 EXP 9/94. Manufacturer: Barre-National, Inc., Baltimore, Maryland. Recalled by: Manufacturer, by letter Oct. 28, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. 38,098 bottles were distributed; firm estimates 3,334 bottles remain on the market. Reason: Zinc Oxide ingredient outside of potency specification. CLASS III -- COMPRESSED MEDICAL GAS, OXYGEN, USP In D, ME, and M size cylinders. Recall number: D-132-2. All lots. Manufacturer: All Care Medical, Inc., Lexington, Kentucky. Recalled by: Manufacturer, by visit Sept. 5, 1991. Firm-initiated recall complete. Distribution: Kentucky. 46 cylinders were distributed. Reason: Current good manufacturing practice deficiencies. CLASS III -- HYDROCORTISONE 0.5% CREAM In 30 gram, 15 gram, and in 1 pound sizes. Recall number: D-105-2. Lot numbers (30 gm) 5515, 5763, 5803, 7185, 7219, 7233, 7267, 7547, 8296, 8363, 8434, 8678, 8679, 8756, 9210, 9211, 9322; (15 gram) 5763; (1 lb) 7267. Manufacturer: Pharmafair, Inc., Hauppague, New York. Recalled by: Manufacturer, by letter dated Sept. 23, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. 197,500 units of 30 gram size, 2,570 units of 15 gram size and 120 units of the 1 pound size were distributed. Reason: Lack of stability data to support expiration date. CLASS III -- IBUPROFEN TABLETS 200 mg, in bottles of 100, an OTC drug used for pain and fever reduction. Recall number: D-122-2. Lot number A01291 EXP 12/93. Manufacturer: Interpharm, Inc., Plainview, New York. Recalled by: Manufacturer, by letter Nov. 25, 1991. Firm-initiated recall ongoing. Distribution: Texas, New Jersey, Virginia, California, Ohio, Georgia. 14,688 bottles were distributed; firm estimates 50 percent remains on the market. Reason: Product exceeds Abbreviated New Drug Application specifications for degradation product. CLASS III -- LACTULOSE SYRUP USP A Rx drug sold under the names of Constulose in 8 and 32 ounce bottles and Enulosein 16 and 64 ounce bottles. Recall number: D-116- 2. Lot number 13407 EXP 5/93, 11/92. Manufacturer: Barre-National, Inc., Baltimore, Maryland. Recalled by: Manufacturer, by letter Nov. 6, 1991. Firm-initiated recall ongoing. Distribution: Nationwide, Puerto Rico. 31,278 bottles were distributed; firm estimates 11,736 bottles remain on the market. Reason: Product contained particulate matter. CLASS III -- NITRO-BID BRAND NITROGLYCERIN CONTROLLED-RELEASE CAPSULES (a) 2.5 mg, in 60 and 100 count bottles and bulk in 25,000 capsule drums; (b) 6.5 mg, in 100 count bottles and bulk in 25,000 capsule drums; (c) 9.0 mg, in 100 count bottles and bulk in 25,000 capsule drums, a Rx oral administered product for the management, prophylaxis, or treatment of anginal attacks. Recall number: D- 118/120-2. (a) all lots which range in expiration dates from 9/91 to 6/93; (b) RE, TA, BL, HF, HC, KN, NF, NG, NT, PA, PC (60 count bottles), RF, SA, CC, CE, CB, CP, CR, EF, EH, ET, FA, FP, GL, GM, GN, HM, HN, GP, GR, HR, JA, JB, JK, JL, JM, KL, KM, NN, LE, LG, ME, MH, MK, NP, NS (100 count bottles); (c) CK, EA, HH, NA (60 count bottles), CF, CS, EB, EL, KH (100 count bottles). Manufacturer: Marion Merrell Dow, Inc., Kansas City, Missouri. Recalled by: Manufacturer, by letter Sept. 30, 1991. Firm-initiated recall ongoing. Distribution: Nationwide and international. (a) 1,991,966 bottles and 8 bulk drums; (b) 229,022 bottles; (c) 86,816 bottles were distributed. Reason: Potency may not remain in specification through expiration date. CLASS III -- ORA5 A topical bactericidal agent for oral mucosa, in 1 ounce brown glass bottles. Recall number: D-103-2. Lot 63. Manufacturer: Summer Laboratories, Fort Washington, Pennsylvania. Recalled by: McHenry Laboratories, Inc., Edna, Texas, by letter Oct. 15, 1991. Firm- initiated field correction ongoing. Distribution: Nationwide. 2,620 bottles were distributed; firm estimates 524 bottles remain on the market. Reason: Subpotent in iodine content. CLASS III -- PIPRACIL Sterile piperacillin sodium, in 40 gram vials for IM and IV use as a broad spectrum antibiotic. Recall number: D-104-2. Lot numbers: 313- 712, 315-706, 315-707, 315-708, 315-709, 315-710, 315-711. Manufacturer: Lederle Parenterals Inc., Carolina, Puerto Rico. Recalled by: Lederle Laboratories, Pearl River, New York, by telephone Oct. 4, 1991 followed by letter Oct. 25, 1991. Firm- initiated field correction ongoing. Distribution: Nationwide. 20,844 vials were distributed. Reason: The outer box incorrectly declares 180 ml of sterile water to be added instead of the correct 172 ml. The container label and package insert are correct. CLASS III -- ROBITUSSIN (GUAIFENESIN SYRUP, USP) EXPECTORANT In 4 ounce bottles (sealed in shipping cases only) and Robitussin DM Cough Suppressant-Expectorant, in 4 ounce bottles (unit cartons in open shelf stock). Products are OTC cough formulas. Recall number: D-121-2. Unit cartons in open shelf stock -- lot numbers 91 4108-9, 91 4109-9, 91 4113-10, and 91 4114-10. Sealed shipping cases -- lot numbers 4108, 4109, 4113, 4114. Manufacturer: Consumer Products Division, A. H. Robins Company, Richmond, Virginia. Recalled by: Manufacturer, by letter Dec. 2, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. 174,864 (lot 4108), 181,080 (lot 4109), 76,464 (lot 4113), 47,664 (lot 4114) containers were distributed. Reason: Some bottles of Robitussin Syrup were packed in unit cartons labeled Robitussin DM. CLASS III -- RUGBY BRAND RED ENTERIC COATED ASPIRIN 5 grain tablets for arthritis, in 100 tablet bottles, an OTC product indicated for the temporary relief of minor aches and pains due to colds, rheumatism and arthritis. Recall number: D-124-2. Lot numbers P7198 EXP 9/93, P7272 EXP 10/93. Manufacturer: LNK International, Hauppauge, New York. Recalled by: Manufacturer, by telephone. Firm- initiated recall ongoing. Distribution: Undetermined. 6,396 bottles were distributed. Reason: Front label correctly declares 5 grain strength. Back label incorrectly declares 10 grain strength. CORRECTION -- DIHISTINE DH ELIXIR; DIHISTINE EXPECTORANT; GUIATUSS DAC The Enforcement Report of Sept. 18, 1991 "The Pink Sheet" Sept. 23, 1991, T&G-12 incorrectly stated that all lots within expiration dates were under recall for Recall number: D-633/636-1. The following is a corrected list of lot numbers: Dihistine DH Elixir -- 82603 EXP 12/93, 92156 EXP 4/92, 92157 EXP 3/92, 92211 EXP 4/92, 92389 EXP 6/92, 92653 EXP 10/92, 92844 EXP 1/93, 02083 EXP 3/93, 03285 EXP 4/93, 03378 EXP 6/93; Disistine Expectorant -- 82597 EXP 12/91, 92103 EXP 3/92, 92315 5/92, 92556 9/92, 92789 EXP 11/92, 02085 EXP 3/93, 03254 EXP 5/93, 03377 EXP 7/93; Guiatuss AC -- 72467 EXP 9/91, 72666 EXP 1/92, 82092 EXP 2/92, 82231 EXP 4/92, 82598 EXP 11/92, 82449 EXP 8/92, 92036 EXP 2/93, 92195 EXP 3/93, 92196 EXP 4/93, 92319 EXP 5/93, 92320 EXP 6/93, 92466 EXP 8/93, 92665 EXP 9/93, 92787 EXP 12/93, 02021 EXP 2/94, 02090 EXP 3/94, 03173 EXP 4/94, 03286 EXP 5/94, 03287 EXP 5/94, 03350 EXP 6/94; Guiatuss DAC -- 92633 EXP 10/91, 92849 EXP 2/92, 92849A EXP 2/92, 03175 EXP 3/92, 03358 EXP 6/92. INJUNCTION ACTION FILED -- VITAMIN, MINERAL, HERBAL AND GLANDULAR PRODUCTS Against: Enzymatic Therapy, Inc., et al., Green Bay, Wisconsin. Charge: Unapproved therapeutic claims were made for the products. Filed: Nov. 1, 1991 -- U.S. District Court for the District of Wisconsin; Civil number 91-C-1174, INJ number 1232. SEIZURE ACTIONS FILED -- AMINO ACID TABLETS (L-ORNITHINE) Charge: Misbranded -- The labeling is false or misleading and the products are new drugs for which no approved New Drug Application exists. Firm: Nat-Rul Health Products, Inc., Chestnut Ridge, New York. Filed: Aug. 21, 1991 -- U.S. District Court for the Southern District of New York; Civil number 91CV-5671 (KMW), FDC number 66245. Seized: Sept. 5, 1991. SEIZURE ACTIONS FILED -- AMINO ACID TABLETS (TAURINE W/B-6 TABLETS) Charge: Misbranded -- The labeling is false or misleading and the products are new drugs for which no approved New Drug Application exists. Firm: Rugby/Darby Group Company, Rockville Centre, New York. Filed: Oct. 25, 1991 -- U.S. District Court for the Eastern District of New York; Civil number 91-4173, FDC number 66255. Seized: Dec. 5, 1991; seizure of 236 bottles, plus 2,000 copies of the current catalog and 55,600 copies of a new edition of the catalog was accomplished.