PUREPAC INADEQUATE PRODUCT FAILURE INVESTIGATIONS CITED IN WARNING LETTER
Executive Summary
PUREPAC INADEQUATE PRODUCT FAILURE INVESTIGATIONS CITED IN WARNING LETTER sent by FDA's Newark District Office to the company on Nov. 23. The warning letter describes product failure investigations for propoxyphene napsylate with APAP and trazodone tablets that resulted in the release into distribution of the products. The warning letter stems from an FDA inspection conducted Sept. 12 to Oct. 18. FDA said it is in the process of reviewing Purepac's response to the FD-483 issued following the inspection.