Recalls / Class III
Class IIID-0983-2017
Product
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
- Affected lot / code info
- Lot #: 30227613A, 30227614A, 30227615A, EXP 6/2017; 30228559A, 30228560A, EXP 9/2017; 3000123, EXP 7/2018
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 25264 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-06-29
- FDA classified
- 2017-07-14
- Posted by FDA
- 2017-07-26
- Terminated
- 2018-04-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0983-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.