FDANovember 9, 2021drug

Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05

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

The hazard

Crystallization; identified as Buprenorphine free base

What to do

FDA enforcement status: Terminated

Brands named

par sterile productsparpar sterile

Recall history

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

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