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Chart: FDA Recalls & Court Actions for Dec. 21, 2005

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Executive Summary

FDA Recalls & Court Actions



FDA Recalls & Court Actions

Dec. 21, 2005

CLASS II

Methotrexate Active Pharmaceutical Ingredient

Bulk powder, 10 kg, 10.5 kg and 20 kg drums, Rx only - For manufacturing, processing, or repacking, NDC 12780-0491-0, CAS-59-05-2, Batch No. 1098057; 1097859; 1101822; 1098687.

Manufacturer:

Orion Corporation, Fermion, Espoo, Finland.

Recalled by:

SST Corporation, Clifton, NJ, by e-mail. Firm-initiated recall is ongoing.

Distribution:

IL, OH, VA, and PR; 140.5 kg.

Reason:

Methotrexate API contaminated with ethylene glycol during manufacture.

Recall number:

D-064-6.

CLASS III

Darvon Compound

(Propoxphene hydrochloride, aspirin and caffeine capsules), USP 65 mg, NDC 66591-612-41, 100 pulvules, Rx only, Lot 03246A, 03247A, 03248A, 04190A, 04210A, 05015A, 05029A, 05057A, 05057B.

Manufacturer:

aaiPharma, Wilmington, NC. Firm-initiated recall is ongoing.

Recalled by:

Xanodyne Pharmaceuticals, Inc., Florence, KY, by letter starting Dec. 8, 2005. Firm-initiated recall is ongoing.

Distribution:

Nationwide; 85,252 bottles/100 count bottles.

Reason:

Dissolution failure: aspirin and propoxyphene hydrochloride (18 month stability).

Recall number:

D-065-6.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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