FDA RECALLS & COURT ACTIONS: Feb. 19, 1992

Executive Summary

CLASS II -- MEPERIDINE HYDROCHLORIDE INJECTION, USP 25 mg/ml, in 1 ml vials, a Rx narcotic analgesic. Recall number: D-213-2. Lot number 061154 EXP 3/93. Manufacturer: Elkins-Sinn, Inc., Cherry Hill, New Jersey. Recalled by: Manufacturer, by letter dated Jan. 20, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. Firm estimates 68,766 vials remain on the market. Reason: A vial of Meperidine was found mislabeled as Robinul Injection. CLASS III -- DIGOXIN TABLETS, USP 0.25 mg, in bottles 1000 and 5000 tablets, a Rx drug under the following labels: Zenith, Aligen, Best Generics, Bioline, Dixon Shane, Goldline, Glenlawn, H.L. Moore Drug Exchange, Interstate Drug Exchange, Rugby, Schein, United Research Laboratories. Recall number: D-212-2. All lots. Manufacturer: Zenith Laboratories, Inc., Northvale, New Jersey. Recalled by: Manufacturer, by letter dated July 17, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. Firm estimates 487 bottles of 1,000 tablets and 50 bottles of 5,000 tablets remain on the market. Reason: Product does not meet dissolution specifications.