September 03, 2020
Hikma Pharmaceuticals USA Inc. is recalling 97,890 vials of buprenorphine hydrochloride injection over subpotency concerns, according to the September 2, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects buprenorphine hydrochloride injection, 0.3 mg/mL, 1-mL vials (NDC 0143-9246-01) from lots 2005023.1, 2005024.1, and 2005025.1 (Exp. 2/28/21). The affected vials were distributed throughout the United States.
Hikma Pharmaceuticals USA initiated the voluntary recall August 14, 2020. On August 21, 2020, the FDA designated the recall Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Buprenorphine hydrochloride injection is a prescription narcotic indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.