Recalls / Class III

Class IIID-0578-2018

Product

Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56

Affected lot / code info

All lots within expiry.

Why it was recalled

Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.

Recalling firm

Firm

Teva Pharmaceuticals USA

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1090 Horsham Rd, North Wales, Pennsylvania 19454-1505

Distribution

Quantity

1,157,095 bottles

Distribution pattern

Distributed throughout the United States

Timeline

Recall initiated

2018-02-05

FDA classified

2018-03-05

Posted by FDA

2018-02-21

Terminated

2019-04-30

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0578-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.