Drug recall D-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,
Reason for recall
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).
Lots and codes
Lot # 17220002, Exp Date 11/30/2023
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 8,448 30-count bottles, 168 1000-count bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 23, 2023
- Terminated
- July 5, 2024
Related products
- Esomeprazole Magnesium – drug information
- NDC 68462-391 Esomeprazole Magnesium · Esomeprazole Magnesium 40 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-390 Esomeprazole Magnesium · Esomeprazole Magnesium 20 mg/1 · Glenmark Pharmaceuticals Inc., USA