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FDA RECALLS & COURT ACTIONS: Sept. 16 & 23, 1992

Executive Summary

CLASS I -- CLOZARIL (CLOZAPINE) 100 mg SandoPak (unit dose pack), 100 tablets, a Rx anti-psychotic drug. Recall number: D-497-2. All lots on the market as of 7/31/92. Manufacturer: Sandoz Pharmaceuticals Corporation, East Hanover, New Jersey. Recalled by: Manufacturer, by letters dated July 24 and 31, 1992. Firm-initiated field correction ongoing. Distribution: Nationwide; firm estimates 1,000 SandoPaks remain on the market. Reason: Some blister cavities of the unit dose strips contained two tablets instead of one. CLASS II -- (a & b) ENGLISH PLANTAIN ALLERGENIC EXTRACT; (c) CUSTOM WEED MIX ALLERGENIC EXTRACT (a) In 50 ml vials; (b) in 30 ml vials; (c) in 50 ml vials. Recall number: B-330/332-2. Lot numbers: 54-68-2A1; (b) 54-68-2A2; (c) P0275-70-1A1. Manufacturer: Greer Laboratories, Inc., Lenoir, North Carolina. Recalled by: Manufacturer, by telephone May 7, 1992. Firm- initiated recall complete. Distribution: North Carolina, South Carolina, Connecticut, Oregon, Kentucky, Florida, Kansas, Texas; (a) 19 vials; (b) 1 vial; (c) 1 vial. Firm estimates none remains on the market. Reason: Allergenic extracts, labeled with the incorrect type of allergen, were distributed. CLASS II -- RITALIN (METHYLPHENIDATE HCl) 20 mg, 100 tablets, a Rx product for oral administration as a central nervous system stimulant. Recall number: D-498-2. Lot numbers: 1B005856 EXP 11/96, 2B005856 EXP 11/96, 1B006379 EXP 12/96. Manufacturer: Ciba-Geigy Corporation, Pharmaceutical Division, Summit, New Jersey. Recalled by: Manufacturer, by letter July 14, 1992, followed by telephone. Firm-initiated recall ongoing. Distribution: Nationwide and international; 28,476 units of lot 1B005856, 6,814 units of lot 2B005856, and 33,354 units of lot 1B006379 were distributed; firm estimates 20,500 units remain on the market. Reason: An incorrect National Stock Number (NSN) intended for Ritalin-SR 20 mg was an error printed on the Ritalin 20 mg label. CLASS II -- Rx SMALL VOLUME PARENTERALS IN PREFILLED SYRINGES (a) Heparin Lock Flush Solution, USP, 100 units/ml, in 3 ml syringes, catalog number 10773 and 5 ml syringes, catalog number 10775, with the 3 ml syringe also packaged in the Lok-Pak-N Heparin Lock Flush Procedure Pack, catalog number 11873; (b) Sodium Chloride Injection, USP, 0.9%, Preservative Free, in 2 ml syringe, catalog number 11272, packaged in the Lok-Pak-N Heparin Lock Flush Procedure pack, catalog number 11771. Recall number: D-495/496-2. Lot numbers: (a) 91M003B (5 ml), 91M004D (3 ml), 91M004C (Kit number 11873); (b) 91M002 (2 ml), 91M001B (kit number 11771). Manufacturer: Smith & Nephew SoloPak, Franklin Park, Illinois. Recalled by: Smith & Nephew SoloPak, Elk Grove Village, Illinois, by letters dated Aug. 18, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; (a) 55,560 3-ml syringes, 115,200 3-ml syringes in kits, and 92,280 5-ml syringes; (b) 163,320 2-ml syringes in kits were distributed; firm estimates that 10 percent of the product remains on the market. Reason: Lack of assurance of sterility. CLASS II -- VARIOUS LYPHOMED Rx INJECTABLE DRUG PRODUCTS (a) Aminophylline Injection, USP, 25 mg/ml, in 20 ml vials; (b) Atropine Sulfate Injection, USP, 0.5 mg/ml, in 1 ml vials; (c) Cyanocobalamin Injection, USP, 1,000 mcg/ml, in 1 ml vials; (d) Diazepam Injection, USP, 5 mg/ml, in 2 ml vials; (e) Heparin Lock Flush Solution, 10 USP units/ml, in 1 ml vials; (f) Heparin Sodium Injection, USP, 10,000 USP units/ml, in 1 ml vials; (g) Lidocaine HCl Injection, USP, 2%, 20 mg/ml, in 2 ml vials; (h) Mannitol Injection, USP, 25%, 250 mg/ml, in 50 ml vials; (i) Multilyte-20 Multi-Electrolyte Concentrate, in 25 ml vials; (j) Phenytoin Sodium Injection, USP, 50 mg/ml, in 2 ml and 5 ml vials; (k) Potassium Chloride for Injection Concentrate, USP, Preservative Free, 2 mEq/ml, in 10 ml vials, and in 20 ml vials; (l) Potassium Chloride for Injection Concentrate, USP, 2 mEq/ml, preserved, in 20 ml vials; (m) Pyridoxine Hydrochloride Injection, USP, 100 mg/ml, in 1 ml vials; (n) Sodium Chloride Injection, USP, 23.4%, in 30 ml vials; (o) Sterile Water for Injection, USP, in 5 ml vials, 50 ml vials, and 100 ml vials; (p) Thiamine Hydrochloride Injection, USP, 100 mg/ml, in 2 ml vials. Recall number: D-503/518-2. Lot numbers: (a) 320114, 320290, 320291; (b) 311244; (c) 311250, 320371; (d) 320324; (e) 311199, 311210, 311307, 320024, 320120, 320186, 320158, 320168, 320208, 320214, 320354, (f) 311213, 311299, 311302, 320105, 320111, 320195, 320451; (g) 311238; (h) 310131, 310133, 310132, 310968, 320012, 320011; (i) 320344; (j) 311288, 320044, 320129; (k) 311277, 320078, 311248, 320072, 320312; (l) 311340; (m) 311245, 320155; (n) 320403, 320185; (o) 311366, 320172, 311258, 320322; (p) 320159, 320331. Manufacturer: Lyphomed, Division of Fujisawa USA, Inc., Grand Island, New York. Recalled by: Lyphomed, Division of Fujisawa USA, Inc., Melrose Park, Illinois, by letter Aug. 28, 1992. Firm- initiated recall ongoing. Distribution: Nationwide, The Bahamas, Nicaragua, Hong Kong, Peru, Malta. Vials distributed/estimated to remain on market: (a) 87,100/43,450; (b) 56,250/11,250; (c) 233,150/47,295; (d) 88,790/48,660; (e) 1,927,625/269,868; (f) 1,448,150/260,667; (g) 42,350/4,930; (h) 124,775/36,491; (i) 8,750/4,275; (j) 108,182/59,540; (k) 292,800/38,521; (l) 53,150/6,798; (m) 77,325/31,199; (n) 86,475/24,213; (o) 116,325/29,994; (p) 119,975/48,306. Reason: The vials have a low fill volume. CLASS II -- VARIOUS Rx AND OTC DRUG PRODUCTS REQUIRING REFRIGERATED STORAGE CONDITIONS (a) Repository Corticotropin Injection, USP, ACTH, in 5 ml vials: (i) 40 units/ml, Major item number 179606; (ii) 80 units/ml, Major item number 184143; (b) Major Naphazole A Ophthalmic Solution, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3% Ophthalmic Solution, USP (Sterile), in 15 ml dropper container, Major item number 135418; (c) Major Sulfacetamide Sodium Ophthalmic Solution, USP, 10% (Sterile), in 15 ml bottle, Major item number 129155; (d) Acetaminophen Suppositories: (i) Mapap Pediatric Rectal Suppositories, Acetaminophen 120 mg, 12 suppositories per box, Major item number 127449, M-11 on box; (ii) G & W Acephen Acetaminophen Rectal Suppositories, Acetaminophen 325 mg, 12 suppositories per box, Major item number 184200; (iii) Mapap Rectal Suppositories, Acetaminophen 650 mg, 12 suppositories per box, Major item number 127464, M-11 on box; (e) G & W Truphylline Aminophylline Suppositories, 500 mg, 10 suppositories per box, Major item number 184150; (f) Major Phenameth Promethazine HCl Suppositories, 50 mg, 12 and 25 suppositories per box, Major item number 153866; (g) Major Erythromycin Ethylsuccinate Oral Suspension, in 1 pint bottles: (i) 200 mg/5 ml: Major item number 140293; (ii) 400 mg/5 ml: Major item number 140301; (h) Major Erythromycin Estolate Oral Suspension, USP, in 1 pint bottles, store in refrigerator to preserve taste: (i) 125 mg/5 ml: Major item number 140319; (ii) 250 mg/5 ml: Major item number 140335. Recall number: D-482/494-2. Code: Ellis Division Ormond Beach, FL, Woburn, MA and Winston Salem, NC locations: All products, all lots within expiration date; Murray Division, Murray, KY and Houston, TX locations: items a, b, c, g, h; all lots within expiration date; Crown Division Chicago, IL and Omaha, NE locations: items b, e, f (12's): All lots; item c, lot number 0693 and 0398 only; item g -- ii, lot number 0020 only; item a -- i, all lots, Omaha customers only; Michigan Division, Auburn Hills, MI location: item b, lot 0874 only; item d -- ii, all lots; item h -- ii, lot number 13097 only; Ultra Division, Seattle, WA and San Diego, CA locations: items b, f: all lots; item c, all lots for Seattle and lot 9764 only for San Diego. Manufacturer: (a) Organics/LaGrange, Chicago, Illinois; (b, c, g) Pharmafair, Inc., Tampa, Florida; (b, c) Bausch & Lomb Pharmaceuticals, Clearwater, Florida; (d, e, f) G & W Laboratories, Inc., South Plainfield, New Jersey; (g, h) Barre- National, Inc., Baltimore, Maryland. Recalled by: Major Pharmaceuticals, Chicago, Illinois (responsible firm), by letter Aug. 25, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; 189 vials of 40 u/ml and 417 vials of 80 u/ml repository corticotropin; 10,540 bottles of Naphazole A; 48,011 bottles of Sulfacetamide; 1,108 125-mg, 420 325-mg, & 1,119 650-mg boxes of acetaminophen suppositories; 214 boxes of aminophylline suppositories; 801 X 12 and 121 X 25 boxes of promethazine HCl suppositories; 713 200-mg and 562 400-mg bottles of erythromycin ethylsuccinate; and 168 125-mg and 495 250-mg bottles of erythromycin estolate were distributed which had not been refrigerated. The firm estimates that 10% of the product remains on the market. Reason: The products were not held at the labeled storage temperatures, which could affect the products' potency and/or physical properties. CLASS III -- BEN-AQUA GEL 5% (BENZOYL PEROXIDE 5%) In 4 ounce tubes. Recall number: D-499-2. Lot number H282 EXP 12/93. Manufacturer: Syosset Laboratories Company, Inc., Syosset, New York. Recalled by: Manufacturer, by letter Aug. 6, 1992, followed by telephone Aug. 7, 1992. Firm-initiated recall ongoing. Distribution: California, New Mexico, Minnesota, New York, New Jersey; 918 units were distributed. Reason: Some tubes have leakage at the crimp. CLASS III -- (a) THORAZINE; (b) THORAZINE SYRUP (Chlorpromazine Hydrochloride) Concentrate 30 mg/ml, in 4 fluid ounce bottles; (b) 10 mg/5 ml in 4 fluid ounce bottles. Recall number: D-501/502-2. Lot numbers: (a) X1-1T47 EXP 6/30/95; (b) X3- 0T72 EXP 11/30/93, X4-0T72 EXP 11/30/93, X5-0T72 EXP 11/30/92, X6- 1T72 EXP 9/30/94, X7-1T72 EXP 9/30/94, X8-1T72 EXP 9/30/94, 2-2T72 EXP 2/28/95, 3-2T72 EXP 3/31/95. Manufacturer: SmithKline Beecham Pharmaceuticals Company, Cidra, Puerto Rico. Recalled by: Manufacturer, by letter mailed Aug. 11, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; (a) 4,120 bottles were distributed; firm estimates none remains on the market; (b) 35,905 bottles were distributed; firm estimates 4,000 bottles remain on the market. Reason: (a) Product does not meet pH specifications; (b) Potency not assured if continuously stored at upper temperature limit. CLASS III -- TRIAMCINOLONE ACETONIDE CREAM 0.1%, 80 gram size. Recall number: D-500-2. Lot number H208 EXP 10/93. Manufacturer: Syosset Laboratories Company, Inc., Syosset, New York. Recalled by: Manufacturer, by letter Aug. 13, 1992. Firm- initiated recall ongoing. Distribution: Florida, Illinois; 1,208 tubes were distributed. Reason: Some tubes have leakage at the crimp. CLASS III UPDATE -- IBUPROFEN TABLETS Ibuprofen Tablets, Recall number: D-456-2. Manufactured by: Boots Pharmaceuticals, which appeared in the Aug. 19, 1992 Enforcement Report ("The Pink Sheet" Aug. 31, T&G-12) is the Rx drug.
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