Drug product
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56
D-0517-2017
Product summary
- Event
- Event 76432
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,628 HDPE bottles (228,840 tablets)
- Official record key
drug-enforcement:D-0517-2017
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot 30227056A; Exp. 03/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications