February 2021 FDA Recall Buprenorphine And Naloxone by Alvogen, Inc
D-0649-2021 - Subpotent drug
This Class II drug recall was voluntarily initiated by Alvogen, Inc on February 26, 2021 for the product Buprenorphine And Naloxone. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0649-2021
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
02-26-2021
07-14-2021
9,696 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Alvogen, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
02-16-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 36924, Exp 6/2021
