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FDA RECALLS & COURT ACTIONS: February 24, 1993

Executive Summary

CLASS II - ORIDOL-DM LIQUID Rx liquid oral antitussive/mucolytic-expectorant, 10 mg, packaged in 16 ounce brown plastic bottles with white plastic caps, under the following labels: LuChem, Qualitest, and Major. Recall number: D-138-3. Lot 6292 EXP 9 94. Manufacturer: H.N. Norton & Company (formerly LuChem Pharmaceuticals, Inc.), Shreveport, Louisiana. Recalled by: Manufacturer, by letter on or about Dec. 28, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; 2,794 units under the LuChem label, 10,000 units under the Qualitest label, and 744 units under the Major label were distributed. Reason: One or more bottles of Oridol-C was mislabeled as Oridol-DM. CLASS II - REDI-SCRIPT CEPHALEXIN CAPSULES USP A Rx antibiotic, in bottles labeled to contain 100 500-mg capsules. Recall number: D-139-3. Labels do not bear a lot number or expiration date. Manufacturer: Prepackage Specialists, Division of PDRx Pharmaceuticals, Inc., Oklahoma City, Oklahoma (repacker/own label distributor). Recalled by: Repacker, by telephone Feb. 1, 1993, followed by letter dated Feb. 2, 1993. Firm-initiated recall ongoing. Distribution: New Jersey, California, Illinois; 9,504 bottles were distributed; firm estimates that little, if any, of the lot remains on the market. Reason: Some bottles labeled as 500 mg strength contain 250 mg capsules. CLASS III - CHEM-TUSS ELIXIR A liquid antihistaminic, nasal vasoconstrictor Rx drug, packaged in 16 ounce brown plastic bottles. Recall number: D-144- 3. Lot number 5915 EXP 4/95. Manufacturer: H.N. Norton & Company (formerly LuChem Pharmaceuticals, Inc.), Shreveport, Louisiana. Recalled by: Manufacturer, by letter on or about Nov. 3, 1992. Firm-initiated recall complete. Distribution: Nationwide; 104 units were distributed. Reason: Product contains excess FD&C Blue number 1 color. CLASS III - COTATATE DH SYRUP Under the Major label, a liquid oral antitussive/expectorant Rx drug consisting of hydrocodone bitartrate, 5 mg, and guaifenesin, 100 mg, packaged in 16 ounce brown plastic bottles. Recall number: D-137-3. Lot number 5871 EXP 3/94. Manufacturer: H.N. Norton & Company (formerly LuChem Pharmaceuticals, Inc.), Shreveport, Louisiana. Recalled by: Manufacturer, by letter on or about Dec. 28, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; 3,428 units were distributed. Reason: Product does not meet stability specifications. CLASS III - RX DRUGS FOR INJECTION In partial additive plastic I.V. bag, called PAB bag: (a) 5% Dextrose USP, 100 ml, 50 ml, and 25 ml; (b) 0.9% Sodium Chloride USP, 100 ml, 50 ml; (c) 0.4% Theophylline and 5% Dextrose, 100 ml, 50 ml; (d) Metronidazole USP, 100 ml. Recall number: D-140/143-3. Lot numbers: (a) J2N931, J2N932, J2N938, J2N941, J2N942 (100 ml); J2N924, J2N925, J2N926, N2N927, J2N936, J2N937 (50 ml); J2N923 (25 ml); (b) J2N929, J2N930, J2N934, J2N935, J2N943 (100 ml); J2N939, J2N951 (50 ml); (c) J2N933 (100 ml); J2N928 (50 ml); (d) J2N944. Manufacturer: McGaw, Inc., Irvine, California. Recalled by: Manufacturer, by letter Dec. 21, 1993. Firm-initiated recall ongoing. Distribution: Nationwide, Canada; (a) 239,552 units (100 ml), 71,568 units (50 ml), 19,952 units (25 ml); (b) 316,736 units (100 ml), 341,040 units (50 ml); (c) 5,424 units (100 ml), 2,184 units (50 ml); (d) 74,616 units were distributed. Reason: Some units may contain rubber particulate matter.
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