Drug 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,
D-0112-2024
Product summary
- Event
- Event 93262
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,448 30-count bottles, 168 1000-count bottles
- Official record key
drug-enforcement:D-0112-2024
Official wording
Reason: 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).
Code information: Lot # 17220002, Exp Date 11/30/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification