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PENNEX CLASS III RECALL OF 50 MIL. OTC ANALGESIC, ALLERGY

Executive Summary

PENNEX CLASS III RECALL OF 50 MIL. OTC ANALGESIC, ALLERGY and vitamin tabs is expected to be completed by Aug. 1. The Verona, Pennsylvania company told its customers in a June 26 letter that a credit would be issued for all of the recalled merchandise returned or destroyed. Pennex manufactured the aspirin mainly for private label distribution by a broad range of customers including chain drug stores, supermarkets, independent pharmacy coops, and distributors. The aspirin products were recalled due to trace contamination with aromatic hydrocarbons discovered by the firm as a result of a handful of complaints regarding malodor in bottles. The company explained to its customers that the contamination was introduced by the solvent used in the coating procedure. The solvent, Pennex said, was originally made by Dow Chemical and shipped in bulk to Pittsburgh where it was put into a drum by a local company for Pennex use. Trace levels of the contaminant were apparently introduced into the solvent during shipping, Pennex said, and were not detected by the firm's normal testing procedures which included an assay of the solvent by the USP method. The company explained that "two months later, after many batches of tablets were made using this lot of solvent" the odor was discovered on the finished products, and the decision was made to issue the recall in spite of the fact that no health hazard was involved. Pennex told its customers that in addition to its normal testing procedures, it was instituting "odor tests" on all solvents and all finished tablets.
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