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QUAD RECALL COVERS 93 LOTS OF 15 DRUG ENTITIES

Executive Summary

QUAD RECALL COVERS 93 LOTS OF 15 DRUG ENTITIES, according to a draft version of a letter the firm is sending its wholesalers. The 15 drug entities presumably correlate with the 22 injectable drug products the firm previously announced it would be recalling ("The Pink Sheet" March 26, "In Brief"). The letter instructs wholesalers to "immediately discontinue distributing" the recalled lots and to "return for credit all ampules/vials of these products" to Quad. The letter states that "no safety, efficacy or [GMP] deficiencies have been identified related to these lots" and that "Quad is initiating a voluntary recall...because the products do not conform fully to the terms of their approved ANDAs." The Par subsidiary announced it would initiate the Class III recall March 22 after a March 21 meeting with FDA, stating that the recalls resulted from "minor manufacturing changes in distributed batches [made by Quad] without properly adhering to FDA's regulatory requirements for making such changes." Quad first suspended distribution of 27 products March 16 after internal and external audits revealed the products' manufacturing did not match their ANDAs. The specific ANDA variances involved include overages in active ingredients amounting to 1-2%, and overages of antioxidants and antimicrobial preservatives ranging from 1-10%. Quad's letter to wholesalers reiterates the position of Kenneth Sawyer, president of Par, who maintained in the March 22 release that "there is no evidence that any of these minor changes compromise the safety and effectiveness of these products." He nevertheless concluded that the recall is necessary "to assure the public of the integrity of Quad's product." FDA reportedly has suggested that Quad extend the recall down to the retail level, a request Quad has not yet agreed to, asserting that "the risk to the health and welfare of patients using Quad products containing these minor overages is considered negligible." Quad preliminarily estimated that it would record a $4 mil. charge as a result of the recall. Par's Sawyer noted that "any action taken by Quad, whose products are primarily injectable products sold mainly under the Quad label, would not affect Par's product line, which consists of oral solid, oral liquid, and topical products. He added, however, that the Quad troubles "would have a material adverse impact on Par's consolidated financial position and results of operations."
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PS017206

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