D-0112-2024 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 29, 2023
- Initiation Date
- October 23, 2023
- Termination Date
- July 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,448 30-count bottles, 168 1000-count bottles
Product Description
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).
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 17220002, Exp Date 11/30/2023