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.
Recall initiated: 20200814
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated