Pain Injection Recalled

Par Sterile Products is recalling four lots of buprenorphine hydrochloride injection. According to the November 15, 2023, US Food and Drug Administration (FDA) Enforcement Report, an annual inspection of retained samples revealed the presence of white, crystalline product agglomeration in two of the vials.

The recall affects buprenorphine hydrochloride injection, 0.3 mg/mL, in 1-mL single-dose vials packaged in 5-vial cartons (NDC 42023-179-05), from lots 343716 (Exp. 11/21), 350565 (Exp. 7/22), 26921 (Exp. 7/22), and 36227 (Exp. 2/23). Par Pharmaceutical, Chestnut Ridge, New York, distributed the product throughout the US.

The recall, which was voluntarily initiated by Par Sterile Products on November 9, 2023, was designated Class II by the FDA. Per the classification, use of the affected injection could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Buprenorphine hydrochloride injection is a partial opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.