Opioid Dependence Drug Recalled for Subpotency

Alvogen Inc is recalling a single lot of buprenorphine and naloxone sublingual films because of subpotency, according to the July 14, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects buprenorphine and naloxone sublingual film 2 mg/0.5 mg, 30 pouches containing one sublingual film each (NDC 47781-355-11), from lot 36924 (Exp. 6/21). The product was distributed by Alvogen, Pine Brook, NJ, throughout the United States.

Alvogen voluntarily initiated the recall February 26, 2021. On July 2, 2021, the FDA designated the recall Class II, signaling that use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Buprenorphine and naloxone sublingual film is a controlled substance used for the treatment of opioid dependence.