Recall: D-0649-2021

Class II - Potentially Harmful

Class IIClassification

2021-02-26Initiated

TerminatedStatus

Alvogen, IncFirm

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

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

Distribution

USA nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.