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,

FDA recall notice · announced November 29, 2023 · Glenmark Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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,

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).

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot # 17220002, Exp Date 11/30/2023
Quantity: 8,448 30-count bottles, 168 1000-count bottles
Status: Terminated
Products in this recall event:
- 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, Pharmaceutic (D-0112-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.