Zydus Pharmaceuticals (USA) Inc — Class II: Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus
Zydus Pharmaceuticals (USA) Inc has initiated a Class II recall for Erythromycin Tablets, 250 mg, due to cGMP deviations involving the presence of N-Nitroso-Desmethyl-Erythromycin exceeding the recommended acceptable intake limit.
This affects Zydus Pharmaceuticals (USA) Inc, Zydus Lifesciences Ltd., and pharmaceutical quality and regulatory professionals responsible for monitoring impurity limits and nitrosamine compliance in antibiotic products.
The identification of nitrosamine impurities above acceptable limits suggests potential deficiencies in manufacturing controls or raw material oversight. A Class II designation indicates that while the health hazard is not immediate, the product does not meet regulatory standards for safety and quality, potentially requiring a review of current nitrosamine risk assessments for similar product lines.
Quality teams should verify if any held inventory includes the affected NDCs and ensure nitrosamine testing protocols are sufficient to detect N-Nitroso-Desmethyl-Erythromycin. Regulatory departments should monitor the 'Ongoing' status of this recall for further expansion or closure.
Class II. Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit. Product: Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).. Firm: Zydus Pharmaceuticals (USA) Inc (Pennington NJ United States). Status: Ongoing.
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