Drug product
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03
D-0649-2021
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 87372
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,696 cartons
- Official record key
drug-enforcement:D-0649-2021
Official wording
Reason: Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Code information: Lot #: 36924, Exp 6/2021
Distribution pattern: USA nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent