Drug recall
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc…
FDA recall event 92565 · Class II · Glenmark Therapeutics, Inc.
Key facts
| Event ID | 92565 |
|---|---|
| Recall numbers | D-0939-2023 |
| Recalling firm | Glenmark Therapeutics, Inc. |
| Product type | Drugs |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| 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. |
| Initiation date | May 1, 2023 |
| Report date | Jul 26, 2023 |
| Termination date | Sep 17, 2024 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3015176306 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: