Recalls / Class III
Class IIID-0984-2017
Product
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56
- Affected lot / code info
- Lot #: 30227649A ,30227650A, 30227651A, 30227652A, 30227653A, 30227654A, 30227655A, 30227832A, 30227833A, 30227834A, 30227835A, EXP 06/2017; 30228561A, 30228562A, 30228563A, 30228564A, 30228565A, 30228566A, 30228567A, 30228568A, 30228569A, 30228570A, EXP 9/2017; 3000124, 3000125, EXP 7/2018; 3000392, 3000393, 3000394, EXP 9/2018; 3000872, 3000874, EXP 10/2018;
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
- 196275 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-0984-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.