Class II
Terminated
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.
- Company
- Hikma Pharmaceuticals Usa Inc.
- Recall Initiated
- August 14, 2020
- Posted
- September 2, 2020
- Recall Number
- D-1533-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 97,890 vials
- Firm Location
- Cherry Hill, NJ, United States
Reason for Recall
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot #s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021
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