CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter
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Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).. Generic: ERYTHROMYCIN; Brand: ERYTHROMYCIN. Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit. Classification: Class II. Quantity: 10,992 bottles. Distribution: Nationwide within the U.S
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CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Zydus Lifesciences and Zydus Pharmaceuticals USA recall 600 bottles of Entacavir 1 mg tablets distributed nationwide in the United States. An out-of-specification organic impurity triggered the recall. Stop use immediately and contact a healthcare provider or Zydus for guidance.
Zydus Pharmaceuticals USA Inc. recalls Entecavir tablets after FDA enforcement reports impurity/degradation failures. The recall affects 4,440 bottles distributed nationwide. Providers and patients should stop use and seek guidance from a healthcare professional.
Zydus Pharmaceuticals USA Inc. recalls 4,344 bottles of Entecavir tablets nationwide over impurity/degradation specification failures. The product, Entecavir Tablets, 0.5 mg, carries NDC 68382-920-06 and Lot E309376 with Exp 11/30/2025. The recall is active as of Sept. 24, 2025.
Zydus Lifesciences recall remains active for 270,125 vials distributed across MS, OH, LA and Puerto Rico. The FDA notice cites failed impurities and degradation specifications as the reason. Immediate discontinuation is advised for healthcare providers and patients with ongoing prescriptions. Contact Zydus Pharmaceuticals USA Inc for guidance.