Product: 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
Reason for recall: Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Recall initiated: 20210226
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated