Reported Nov 29, 2023 · Terminated
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b)…
Glenmark Pharmaceuticals Inc., USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle
- NDC 68462-390-10RX Only
- Manufactured forGlenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India
- Lot codes and dates
Lot # 17220002Exp Date 11/30/2023
- Amount recalled
- 8,448 30-count bottles, 168 1000-count bottles
Where it was sold
- Nationwide
Why it was recalled
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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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