D-0983-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 26, 2017
- Initiation Date
- June 29, 2017
- Termination Date
- April 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25264 bottles
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 30227613A, 30227614A, 30227615A, EXP 6/2017; 30228559A, 30228560A, EXP 9/2017; 3000123, EXP 7/2018