Recall: D-1533-2020

Class II - Potentially Harmful

Class IIClassification

2020-08-14Initiated

TerminatedStatus

Hikma Pharmaceuticals USA Inc.Firm

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

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

Distribution

Nationwide in the U.S.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.