Drug recall D-0970-2015
Product
Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01
Reason for recall
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Lots and codes
Lot #: 6A207012, Exp 7/2015.
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Horsham, PA
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 13, 2015
- Terminated
- October 27, 2016
Related products
- Fluoxetine – drug information
- NDC 50111-648 Fluoxetine · Fluoxetine Hydrochloride 20 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 50111-647 Fluoxetine · Fluoxetine Hydrochloride 10 mg/1 · Teva Pharmaceuticals USA, Inc.