Drug recall D-1533-2020
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.
Reason for recall
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Lots and codes
Lot #s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021
Recall details
- Recalling firm
- Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ
- Quantity
- 97,890 vials
- Distribution
- Nationwide in the U.S.
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 14, 2020
- Terminated
- June 10, 2021
Related products
- Buprenorphine Hydrochloride – drug information
- NDC 0143-9246 Buprenorphine Hydrochloride · Buprenorphine Hydrochloride .324 mg/mL · Hikma Pharmaceuticals USA Inc.