Zydus Pharmaceuticals (USA) Inc — Class II: Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactu
Zydus Pharmaceuticals (USA) Inc has initiated a Class II recall for Hydrocortisone Sodium Succinate for Injection, USP (100 mg/vial) due to failure to meet impurities and degradation specifications. The recall remains ongoing and involves products manufactured by Zydus Lifesciences Ltd. in India.
This affects Zydus Pharmaceuticals (USA) Inc, Zydus Lifesciences Ltd., and healthcare providers or distributors utilizing NDC 70710-1907-1. Internally, it impacts Quality Assurance, Manufacturing, and Regulatory departments responsible for impurity monitoring.
A failure in degradation specifications for an injectable product suggests potential issues with product stability or manufacturing controls. For regulatory professionals, this underscores the importance of stringent shelf-life testing and impurity profiling. The Class II designation indicates that while the health hazard is not immediate, the product does not meet the standards required for continued distribution.
Quality teams should review stability data and degradation profiles for existing injectable inventories. Regulatory and supply chain leads should monitor for potential shortages resulting from the ongoing status of this recall and ensure that distribution channels are notified according to the firm's recall strategy.
Class II. Reason: Failed Impurities/Degradation Specifications.. Product: Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1.. Firm: Zydus Pharmaceuticals (USA) Inc (Pennington NJ United States). Status: Ongoing.
Open in openFDA / FDA.gov