Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03

Recall Number: D-0649-2021

Firm: Alvogen, Inc

Classification: Class II

Status: Terminated

Report Date: 20210714

Initiation Date: 20210226

Termination Date: 20220216

Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)

Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03