FDAAugust 14, 2020drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

hikma pharmaceuticalshikma

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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