D-1533-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 2, 2020
- Initiation Date
- August 14, 2020
- Termination Date
- June 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97,890 vials
Product Description
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.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021