PAR Sterile Products LLC recalls Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied…

Recall date

November 9, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0087-2024

FDA classification

Class II

Brand / firm

PAR Sterile Products LLC

Sold / distributed

Nationwide USA

Why it was recalled

Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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