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.

Recall Number: D-1533-2020

Firm: Hikma Pharmaceuticals USA Inc.

Classification: Class II

Status: Terminated

Report Date: 20200902

Initiation Date: 20200814

Termination Date: 20210610

Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.

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.