FDA RECALLS & COURT ACTIONS: August 25, 1993
Executive Summary
CLASS II -- SCANDONEST 3% PLAIN (MEPIVACAINE HYDROCHLORIDE) INJECTION USP, a dental anesthetic in cartridges packed in vacuum cans, 50 cartridges per can. Recall number: D-322-3. Lot number 2B3138 EXP 6/95. Manufacturer: Specialities Sepodont, Paris, France. Recalled by: Deproco, Inc., New Castle, Delaware, by telephone August 9 and 10, 1993, followed by letter August 11, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 142,000 cartridges were distributed. Reason: Some cans labeled Scandonest Cartridges contained Isocaine 2% cartridges. CLASS III -- (A) ETHER, USP; (B) ETHER FOR ANESTHESIA, USP Recall number: D-319/320-3. Lot numbers and sizes: (a) D45626 - 1 L., 4 L., 320 lbs; F39638 - 4 L.; G10601, G22655, G27659 - 1 L., 4 L.; (b) D45629 - 250 ml, 1 L.; D50631 - 250 ml; E16604 - 150 ml, 250 ml, 1 L; E28605 - 250 ml, 1 L, E38640 - 1 L, E45633 - 150 ml, 250 ml, 1 L; E51627 - 150 ml, 250 ml, 1 L; F03623 - 150 ml, 250 ml, 1 L, F39641 - 150 ml, 250 ml, 1 L; F52610 - 150 ml, G05648 - 1 L, G10604 - 1 L, G22658 - 150 ml, 150 ml, 1 L; Ethyl Ether for Anesthesia, Fisher label: 905778 - 150 ml, 1 L, 905790 - 150 ml, 1 L; 912843 - 150 ml, 1 L, 913432 - 1 L, 913819 - 150 ml, 1 L; 914018 - 150 ml, 1 L, 915663 - 150 ml, 1 L, 920052 - 1 L, 922858 - 150 ml, 1 L, 922860 - 150 ml, 1 L, 923072 - 150 ml, 925548 - 150 ml, 925549 - 150 ml; 925550 - 150 ml. Under the labels J. T. Baker and Fisher Scientific. Manufacturer: J. T. Baker, Inc., Jackson, Tennessee (repacker/responsible firm). Recalled by: J. T. Baker, Inc., Phillipsburg, New Jersey, by letter August 6, 1993. Firm-initiated recall ongoing. Distribution: Nationwide, international; (a) 415 packages (all sizes); (b) 7,566 packags (all sizes) remained in commerce at the time of recall initiation. Reason: Products do not meet USP peroxide specification. CLASS III -- ENTERIC-COATED ASPIRIN TABLETS 325 mg, (5 gr) in 100, 200, and 1000 size bottles, under the following labels: J. J. Balan, C. S. Ruckstuhl Co., Inc., Reyman Drug Co., Inc. Recall number: D-321-3. Lot numbers: IB-1021 EXP 2/94, HF-1045 EXP 6/93, HD-1033 EXP 4/93, HD-1032 EXP 4/93, HC-1020 EXP 3/93. Manufacturer: Royce Laboratories, Inc., Miami, Florida. Recalled by: Manufacturer, by letter February 23, 1993. Firm- initiated recall complete. Distribution: Nationwide and Puerto Rico; 2,000,000 tablets from each lot were distributed. Reason: Product does not meet dissolution specification.