FDA-Drug2021-07-14Class II

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

Alvogen, Inc
Hazard

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

Sold states
USA nationwide.
Affected count
9,696 cartons
Manufactured in
44 Whippany Rd Ste 107, Morristown, NJ, United States
Products
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

Official notice

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

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