FDAFDA · Food and drugs·Recall number D-0112-2024
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,
Published November 29, 2023 · Recall initiated: October 23, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide in the USA
- UPC
- 0368462391303
- Lot
- Lot # 17220002, Exp Date 11/30/2023
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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