Drug product
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.
D-1533-2020
Product summary
- Event
- Event 86243
- Status
- Terminated
- Classification
- Class II
- Quantity
- 97,890 vials
- Official record key
drug-enforcement:D-1533-2020
Official wording
Reason: Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Code information: Lot #s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Potency or specification failure
Out-of-Specification