PARMED 1.4 MIL. TABLET/CAPSULE NATIONWIDE RECALL

Executive Summary

PARMED 1.4 MIL. TABLET/CAPSULE NATIONWIDE RECALL of private label products is continuing, according to FDA's Nov. 19 report of recalls and enforcement actions. The recall, initiated by the firm by letter, covers 180 separate drug entitles and dosage forms. FDA noted that the recall was undertaken because of "actual or potential cross-contamination with penicillin and current Good Manufacturing Practice deficiencies." Initiated on Oct. 20, the recall is an extension of a prior recall begun by telephone on Sept. 18. At that time Parmed began recalling 27,600 capsules and tablets, covering 29 separate drug entities and dosage forms. Penicillin contamination was also the reason for the initial recall. The recalled products were supplied to Parmed by various manufacturers, and repackaged by Parmed to private label accounts. However, the firm maintains that it is no longer in the repacking business. Parmed was acquired last May by branded generics manufacturer A.L. Labs, which then selected former wholesale drug industry exec William Altman to head its U.S. pharmaceutical operations last August ("The Pink Sheet" Aug. 11, T&G-1). The acquisition gave A.L. Labs, which formerly operated primarily in Scandanavia and the Far East, an entry into the U.S. market. Based in Fort Lee, NJ, A.L. Labs said that it intended to use Parmed to extend its European branded generics business approach to the U.S. In foreign markets, A.L. Labs has modified the molecular structure of patented drugs to produce patentable improvements such as new indications or delivery characteristics.