FDA recall D-0649-2021

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)

Distribution

USA nationwide.

Key facts

Status

Terminated

Initiation date

2021-02-26

Report date

2021-07-14

Termination date

2022-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morristown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0649-2021