Glenmark Pharmaceuticals Inc., USA is recalling 8,448 30-count bottles and 168 1000-count bottles of Esomeprazole Magnesium Delayed-Release Capsules (20mg). Testing conducted during a long-term stability study revealed that the medication exceeded established safety specifications for organic impurities. No injuries or adverse reactions have been reported in connection with this recall. If you are currently taking this medication, you should consult with your healthcare provider or pharmacist regarding your treatment.
The drug product failed testing for organic impurities, which means the medication may contain degradation products at levels higher than allowed. This could potentially affect the medication's safety or quality over time.
You have 2 options:
Recall #: D-0112-2024; Quantity: 8,448 bottles
Recall #: D-0112-2024; Quantity: 168 bottles
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Sources: FDA iRES · Raw API Response
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