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.
Reported: July 26, 2023 Initiated: May 1, 2023 #D-0939-2023
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.
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.
Details
- Recalling Firm
- Glenmark Therapeutics, Inc.
- Units Affected
- 19,968 bottles
- Distribution
- Nationwide in the USA
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Glenmark Therapeutics, Inc.. Units affected: 19,968 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 26, 2023. Severity: Moderate. Recall number: D-0939-2023.
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