Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvo
Summary
The FDA issued a Class II for Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing by Alvogen, Inc. Reason: Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low).
Details
Source
Drug Recall
External ID
D-0649-2021
Action Date
2021-07-14
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: 36924, Exp 6/2021
Quantity Affected: 9,696 cartons
Reason for Recall
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-02-26
Company
Morristown, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 20 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Alvogen, Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alvogen, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alvogen, Inc have FDA actions?
Alvogen, Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0649-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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