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.
Product description
Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960
Lot numbers, UPCs & expiration codes
Lot #: a) 6A208123, Exp 8/2015; b) 6A208121, Exp 8/2015.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0971-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 13, 2015
- FDA report date
- May 6, 2015
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0971-2015, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 70976
- Address
- 425 Privet Rd
- Code information
- Lot #: a) 6A208123, Exp 8/2015; b) 6A208121, Exp 8/2015.
- Postal code
- 19044-1220
- Report date
- May 6, 2015
- Product type
- Drugs
- Recall number
- D-0971-2015
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Termination date
- Oct 27, 2016
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 13, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 27, 2015