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QUAD TO RECALL 200 LOTS OF 40 PRODUCTS

Executive Summary

QUAD TO RECALL 200 LOTS OF 40 PRODUCTS in the week to 10 days following Feb. 7 due to improper documentation of certain quality control test results. The approximately 40 products involved include anticancer drugs, antibiotics and two or three "grandfathered" trace elements, the injectable generic firm's parent Par said. The recall is expected to cost $ 650,000. Par announced Feb. 7 that the recall will involve "small- volume parenteral products that were manufactured prior to March 26, 1990," when Quad placed a moratorium on distribution of its drugs. Par said it has confidence that there are no documentation problems with any product manufactured after March, when Par took control of Quad operations. Internal investigations disclosed that results of some quality control tests may not have been properly maintained, Par said. As a precautionary measure, Quad will recall all lots and products that may have been affected. Based on the retesting of representative lots involved in the recall, Quad concludes there are no safety or efficacy problems. Quad's recall problems began last March with a call-back of 29 products and a subsequent halt in distribution following the discovery of manufacturing changes that were made without prior FDA approval. At the time, Quad was marketing 65 approved products. Quad is currently shipping about 20 injectable products.
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