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FDA RECALLS & COURT ACTIONS: Oct. 28, 1992

Executive Summary

CLASS II -- ERYTHROMYCIN ESTOLATE ORAL SUSPENSION, USP 250 mg, in 16 ounce bottles, a Rx antibiotic. Recall number: D-048-3. Lot number 03582 EXP 11/92. Manufacturer: Barre-National, Inc., Baltimore, Maryland. Recalled by: Manufacturer, by letter Sept. 29, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; firm estimates 576 units remain on the market. Reason: Subpotency. CLASS II -- OMNIPAQUE INJECTION (IOHEXOL) (a) 300 mg Iodine/ml, 150 ml; (b) 240 mg Iodine/ml, 50 ml and 100 ml; (c) 350 mg Iodine/ml, 50 ml, an opaque aqueous solution used for intrathecal intravascular and oral body cavity contrast enhancement for computerized tomography. Recall number: D-042/044- 3. Lot numbers: (a) B822JJ; (b) B826JJ (50 ml), B823JJ (100 ml); (c) B832JJ. Manufacturer: Sterling Pharmaceuticals, Inc., Barceloneta, Puerto Rico. Recalled by: Sterling Winthrop, New York, New York, by memorandum on or about Sept. 9, 1992. Firm- initiated recall ongoing. Distribution: Nationwide and Canada; 3,364 boxes (10 units per box) were distributed. Reason: Presence of trace quantities of ethylene glycol due to a manufacturing equipment failure. CLASS II -- VARIOUS Rx INJECTABLE DRUG PRODUCTS Manufactured by Lyphomed Div. of Fujisawa USA, Inc: Dacarbazine for Injection, USP, 10 mg/ml when reconstituted, a Rx anti-neoplastic: (a) 100 mg single dose vial; (b) 200 mg single dose vial; Droperidol Injection, USP, 2.5 mg/ml, a Rx tranquilizer; (c) Single dose vials, no preservatives, 2 ml and 5 ml; (d) Multiple dose vials, Preservatives added. 10 ml. Recall number: D-020/023-3. All lots within expiration date. Manufacturer: Lyphomed, Div. of Fujisawa USA, Inc., Melrose Park, Illinois. Recalled by: Manufacturer, by letter Sept. 21, 1992. Firm-initiated recall ongoing. Distribution: (a & b) Nationwide, India, Chile, Peru, Malta, Ecuador, Ireland; (c & d) Nationwide, Hong Kong, Uruguay, Nicaragua, Peru and the Bahamas; firm estimates: (a & b) 35,347 vials; (c & d) 196,151 vials remain on the market. Reason: ANDA discrepancies. CLASS II -- VARIOUS Rx INJECTABLE DRUG PRODUCTS Manufactured by Lyphomed Div. of Fujisawa USA, Inc.: (a) Aminophylline Injection, USP, 25 mg/ml, for the relief of acute bronchial asthma, in 10 ml vials, 20 ml vials; (b) Atropine Sulfate Injection, USP, 0.4 mg/ml, an anticholinergic drug, in 20 ml vials; (c) Atropine Sulfate Injection, USP, 1 mg/ml; an anticholinergic drug; (d) Bacteriostatic Water for Injection, USP; for drug diluent use only, not for use in newborns; 30 ml vials, with methyl & propylparabens, and with benzyl alcohol; (e) Calcium Gluconate Injection, USP, 10%; for treatment of conditions arising from calcium deficiencies; 10 ml vials; (f) Lidocaine Hydrochloride Injection, USP, 4% (40 mg/ml), a local anesthetic for infiltration and nerve block, not for spinal, epidural or intravenous regional anesthesia, in 50 ml vials; (g) Lidocaine Hydrochloride Injection, USP, 2% (20 mg/ml), a local anesthetic for infiltration and nerve block, not for spinal, epidural or intravenous regional anesthesia, in 5 ml vials; (h) Lidocaine Hydrochloride Injection, USP, 1% (10 mg/ml), a local anesthetic for infiltration and nerve block, not for spinal, epidural or intravenous regional anesthesia, 2 ml vials; (i) Mannitol Injection, USP, 25% (250 mg/ml), for intravenous use for the promotion of diuresis, and for urologic irrigation in transurethral prostatic resection, in 50 ml vials, for irrigation and for injection; (j) Neostigmine Methylsulfate Injection, USP, 0.5 mg/ml, for the symptomatic control of myasthenia gravis when oral therapy is impractical, in 10 ml vials; (k) Sodium Chloride Injection, USP, Concentrated, 23.4%, an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion, in 30 ml vials; (l) Sodium Chloride Injection, USP, 0.9%; for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, in 100 ml vials; (m) Sterile Cefazolin Sodium, USP, 1 gram; a semisynthetic cephalosporin antibiotic for parenteral administration for the treatment of serious infections due to susceptible organisms; (n) Sterile Water for Injection, USP; for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, in glass vials: 5 ml vials, 50 ml vials, 100 ml vials; in plastic vials: 10 ml vials, 50 ml vials. Sold also under the Alpha Therapeutics Corporation label; (o) Heparin Sodium Injection, USP, 1,000 USP units/ml, for intravenous or deep subcutaneous administration for anticoagulant therapy for prevention and treatment of blood clots, in 10 ml vials; (p) Heparin Sodium Injection, USP, 10,000 USP units/ml, for intravenous or deep subcutaneous administration for anticoagulant therapy for prevention and treatment of blood clots, in 1 ml vials; (q) Phenytoin Sodium Injection, USP, 50 mg/ml, for the control of grand mal seizures and prevention and treatment of seizures occurring during neurosurgery, in 5 ml vials; (r) Dextrose Injection, USP, 50%; for treatment of severe hypoglycemia due to overdosage of insulin, in 50 ml vials. Recall number: D- 024/041-3. Code: (a) 10 ml: lot number 311167, 311198 20 ml: lot number 301440; (b) lot numbers 320218, 320126; (c) lot numbers 311331, 320425; (d) lot numbers 311188, 320514, 320521, 320520, 320189, 320190; (e) lot numbers 310987, 311175, 311202, 311203; (f) lot number 320234; (g) lot numbers 320228, 320509; (h) lot number 320770; (i) lot numbers 320005, 300282; (j) lot number 310948; (k) lot number 320118; (l) lot numbers 300726, 311125, 311270, 300388, 320778; (m) lot number 320593; (n) 5 ml glass: lot number 320539 50 ml glass: lot number 310291 100 ml glass: lot numbers 300732, 300960, 300961, 300963, 310659 10 ml plastic: lot number 311182 50 ml plastic: lot number 320573 25 ml private label: lot number 310869; (o) lot number 320585; (p) lot number 310706; (q) lot number 311115, 320489; (r) lot number 320833. Manufacturer: Lyphomed, Division of Fujisawa USA, Inc., Grand Island, New York. Recalled by: Fujisawa USA, Inc., also known as Lyphomed, Melrose Park, Illinois. Distribution: Nationwide, United Arab Emirates, The Bahamas, Singapore, Palau, Nicaragua, Hong Kong, Malta; estimated vials to remain on market: (a) 8,270; (b) 3,968; (c) 11,904; (d) 114,867; (e) 10,155; (f) 3,280 (g) 22,959; (h) 10,204; (i) 1,380; (j) 658; (k) 4,020; (l) 4,532; (m) 695 (n) 14,918; (o) 7,260; (p) 23,450; (q) 8,520; (r) 3,200. Reason: Improper vial seal crimp results in a lack of assurance of sterility of the products. CLASS III -- CALMOL 4, OTC HEMORRHOIDAL SUPPOSITORIES Recall number: D-045-3. Lot numbers: A511 EXP 1/96, A521 EXP 1/96, B511 EXp 2/96, B521 EXP 2/96, J511 EXP 10/96, J521 EXP 10/96, J531 EXP 10/96. Manufacturer: The Mentholatum Company, Inc., Buffalo, New York. Recalled by: Manufacturer, by letter on or about Oct. 15, 1992, followed by telephone. Firm-initiated recall ongoing. Distribution: Nationwide; 55,032 cartons (12 or 24 per carton, 12 cartons per case) were distributed; FDA estimates 500 cartons remain on the market. Reason: Carton label not in compliance with labeling provisions of regulation for anorectal products. CLASS III -- M-END LIQUID In 16 ounce bottles, a Rx product. Recall number: D-047-3. Lot number: 13563. Manufacturer: Barre-National, Inc., Baltimore, Maryland. Recalled by: Manufacturer, by telephone Sept. 17, 1992, followed by letter Sept. 29, 1992. Firm-initiated recall ongoing. Distribution: Tennessee; 10,128 units were distributed. Reason: Product subpotent for phenindamine tartrate ingredient. CLASS III -- RESEAU FORMULA TII EDTA for oral chelation therapy, in 60 and 120 capsule bottles. Recall number: D-046-3. All lots. Manufacturer: North West Marketing Company, Pacoima, California. Recalled by: Reseau International, Cincinnati, Ohio (responsible firm), by letter on or about Oct. 17, 1992. Firm-initiated recall ongoing. Distribution: Nationwide, Canada, Bermuda; 2,445 120-capsule size bottles, and 147 60-capsule size bottles were distributed. Reason: Product marketed without new drug approval. CLASS III -- CORRECTION: DIPHENHYDRAMINE HCL CAPSULES Diphenhydramine HCl Capsules, 25 & 50 mg ("The Pink Sheet" Oct. 19, T&G-13). The recall did not include the Rugby label.

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