October 2023 FDA Recall Esomeprazole Magnesium by Glenmark Pharmaceuticals Inc., Usa
D-0112-2024 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on October 23, 2023 for the product Esomeprazole Magnesium. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0112-2024

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).
Initiated
10-23-2023
Reported
11-29-2023
Quantity
8,448 30-count bottles, 168 1000-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93262
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-05-2024
Product Description About Product Description
Full technical description of 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,

Batch or Lot Expiration Information

Lot# 17220002, Exp Date 11/30/2023

Affected Packages Involved in this Recall

68462-390-30 Esomeprazole Magnesium
68462-390-90 Esomeprazole Magnesium
68462-390-10 Esomeprazole Magnesium
68462-391-30 Esomeprazole Magnesium
68462-391-90 Esomeprazole Magnesium
68462-391-10 Esomeprazole Magnesium