Zydus Pharmaceuticals (USA) Inc. is recalling 52,826 units of Esomeprazole Magnesium (the generic version of Nexium) for Delayed-Release Oral Suspension in both 20 mg and 40 mg strengths. The recall was issued because long-term stability testing showed the presence of unknown degradation products, or impurities, that exceeded safe levels. The medication was distributed nationwide in cartons containing 30 single-dose packets.
Testing revealed chemical impurities that formed as the medicine was stored over time. While no injuries have been reported, using medication that contains excessive impurities may reduce the effectiveness of the drug or lead to unintended health side effects.
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Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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