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Chart: FDA Recalls & Court Actions - Sept. 21, 2005

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Executive Summary

FDA Recalls & Court Actions



FDA Recalls & Court Actions

Sept. 21, 2005

CLASS III

Butorphanol Tartrate Nasal Spray

10 mg/mL in a 2.5 mL metered-dose spray pump bottle; a schedule C-IV narcotic analgesic; NDC 60505-0813-1, Lot nos. GN0487, GP4074, GP8357, GP9401, GP9403, GT3173, GT6213, GT6211, GT6215, GV0501, GV0499, GV0503.

Manufacturer:

Apotex Inc., Toronto, Ontario, Canada.

Recalled by:

Apotex Corp., Lincolnshire, IL, by letter dated Aug. 30, 2005. Firm-initiated recall is ongoing.

Distribution:

Nationwide; 160,244 units were distributed.

Reason:

Degradation products: di-butorphanol oxide degradation product levels above the specification limit at nine month stability testing for the impurity.

Recall number:

D-482-5

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