Recalls / Class III
Class IIID-0112-2024
Product
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
- Brand name
- Esomeprazole Magnesium
- Generic name
- Esomeprazole Magnesium
- Active ingredient
- Esomeprazole Magnesium
- Route
- Oral
- NDCs
- 68462-390, 68462-391
- FDA application
- ANDA209495
- Affected lot / code info
- Lot # 17220002, Exp Date 11/30/2023
Why it was recalled
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 8,448 30-count bottles, 168 1000-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-10-23
- FDA classified
- 2023-11-20
- Posted by FDA
- 2023-11-29
- Terminated
- 2024-07-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0112-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.