Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-c
Summary
The FDA issued a Class III for Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-co by Glenmark Pharmaceuticals Inc., USA. Reason: Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 mo.
Details
Source
Drug Recall
External ID
D-0112-2024
Action Date
2023-11-29
Status
Terminated
Category
drug
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,
Lot/Code Info: Lot # 17220002, Exp Date 11/30/2023
Quantity Affected: 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).
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-23
Company
Mahwah, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 38 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Glenmark Pharmaceuticals Inc., USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Glenmark Pharmaceuticals Inc., USA have FDA actions?
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0112-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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