Zydus Pharmaceuticals (USA) Inc — Class II: Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus
Zydus Pharmaceuticals (USA) Inc. has initiated a Class II recall for Erythromycin Tablets, USP, 500 mg (NDC 70710-1048-3) due to CGMP deviations. The specific issue involves levels of N-Nitroso-Desmethyl-Erythromycin exceeding the recommended acceptable intake limit.
This affects Zydus Pharmaceuticals (USA) Inc., Zydus Lifesciences Ltd., and pharmaceutical distributors or healthcare providers handling specific lots of the 500 mg Erythromycin tablet bottles.
The presence of nitrosamine impurities above acceptable limits suggests potential gaps in manufacturing controls or chemical synthesis stability for this active pharmaceutical ingredient. For regulatory professionals, Class II recalls of this nature typically indicate that while the health hazard is not immediate or severe, the product fails to meet safety and quality standards, potentially necessitating a review of impurity assessment reports and CGMP compliance at the manufacturing site.
QA teams should verify if existing Erythromycin tablet stock matches NDC 70710-1048-3. Regulatory and manufacturing teams may need to evaluate supplier controls and impurity testing protocols specifically for nitrosamine levels in erythromycin-based products.
Class II. Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit. Product: 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).. Firm: Zydus Pharmaceuticals (USA) Inc (Pennington NJ United States). Status: Ongoing.
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