Reported Feb 21, 2018 · Terminated
Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD,…
Teva Pharmaceuticals USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only
- Manufactured in Israel byTeva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel
- Manufactured forTeva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
- Lot codes and dates
- All lots within expiry.
- Amount recalled
- 1,157,095 bottles
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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