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Quad recall

Executive Summary

Firm announced March 22 that it will recall 22 generic injectable products, following a March 21 meeting with FDA. The agency told "The Pink Sheet" that at the meeting, the company agreed to a 38-product recall. The impending Class III recall relates to unapproved manufacturing changes for some of the firm's drugs. Quad said it may reintroduce some of these products by manufacturing them according to the original terms of the ANDAs. The company estimates the cost of the recall at about $4 mil. Last week, the Par subsidiary suspended distribution of 27 products as a result of internal and external audits that discovered manufacturing changes made without proper FDA authorization. Quad has not yet agreed with FDA's suggestion that the firm recall the drugs down to the retail level, the agency noted. In a related move, the company announced plans to lay off almost 30% of its 380-employee workforce.
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PS017171

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