Class III
Terminated
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,
- Recall Initiated
- October 23, 2023
- Posted
- November 29, 2023
- Recall Number
- D-0112-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,448 30-count bottles, 168 1000-count bottles
- Firm Location
- Mahwah, NJ, United States
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).
Distribution
Nationwide in the USA
Lot / Code Info
Lot # 17220002, Exp Date 11/30/2023
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