Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Reported: May 7, 2014 Initiated: February 12, 2014 #D-1280-2014
Product Description
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Reason for Recall
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 257904 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.. Recalled by Teva Pharmaceuticals USA. Units affected: 257904 bottles.
Why was this product recalled? ▼
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 7, 2014. Severity: Moderate. Recall number: D-1280-2014.
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