BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
Reported: May 28, 2014 Initiated: April 7, 2014 #D-1325-2014
Product Description
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 53,452 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.. Recalled by Teva Pharmaceuticals USA. Units affected: 53,452 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 28, 2014. Severity: Moderate. Recall number: D-1325-2014.
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