Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
Reported: July 26, 2017 Initiated: June 29, 2017 #D-0983-2017
Product Description
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 25264 bottles
- Distribution
- Nationwide in the USA
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56. Recalled by Teva Pharmaceuticals USA. Units affected: 25264 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 26, 2017. Severity: Low. Recall number: D-0983-2017.
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