Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwa
Summary
The FDA issued a Class II for Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: by Glenmark Therapeutics, Inc.. Reason: Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indi.
Details
Source
Drug Recall
External ID
D-0939-2023
Action Date
2023-07-26
Status
Terminated
Category
drug
Product Description
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.
Lot/Code Info: FA2022001B, Exp 03/2025
Quantity Affected: 19,968 bottles
Reason for Recall
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-01
Company
Mahwah, 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 71 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Glenmark Therapeutics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Glenmark Therapeutics, Inc. have FDA actions?
This is the only FDA action we have on record for Glenmark Therapeutics, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0939-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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