Recalls / Class II
Class IID-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
- Brand name
- Fluoxetine
- Generic name
- Fluoxetine
- Active ingredient
- Fluoxetine Hydrochloride
- Route
- Oral
- NDCs
- 50111-647, 50111-648
- FDA application
- ANDA076001
- Affected lot / code info
- Lot #: 6A207012, Exp 7/2015.
Why it was recalled
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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-04-13
- FDA classified
- 2015-04-27
- Posted by FDA
- 2015-05-06
- Terminated
- 2016-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0970-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.