Status
Terminated
Drug Enforcement D-0112-2024
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).
Classification
Class III
Report Date
November 29, 2023
Termination Date
July 5, 2024
Product Information
- 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,
- Product quantity
- 8,448 30-count bottles, 168 1000-count bottles
- 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).
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Address
-
750 Corporate Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0112-2024
- Event ID
- 93262
- Recall initiation date
- October 23, 2023
- Center classification date
- November 20, 2023
- Code info
- Lot # 17220002, Exp Date 11/30/2023
- More code info
- —