Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.
Reported: May 7, 2014 Initiated: February 12, 2014 #D-1281-2014
Product Description
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.
Reason for Recall
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 72,356 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.. Recalled by Teva Pharmaceuticals USA. Units affected: 72,356 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-1281-2014.
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