Reliance Life Sciences Private Limited — Class II: Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous
Reliance Life Sciences Private Limited has initiated a Class II recall for Pemetrexed for Injection (500mg/vial) due to a lack of sterility assurance. The recall is currently classified as ongoing and affects product manufactured for Somerset Therapeutics, LLC.
Reliance Life Sciences Private Limited, Somerset Therapeutics, LLC., and healthcare providers or distributors handling NDC 70069-0835-01. It specifically impacts personnel in sterile fill-finish operations and quality compliance.
A Class II recall for lack of sterility assurance suggests a potential breakdown in aseptic processing or environmental controls at the manufacturing facility. While the source does not detail a specific contamination event, such a failure typically necessitates a thorough investigation into sterilization validation, container closure integrity, or cleanroom protocols. For an injectable product, this represents a significant compliance risk that could lead to broader site inspections.
Quality teams should review environmental monitoring and media fill data associated with the manufacturing site. Supply chain managers should assess inventory for the specific NDC (70069-0835-01) to facilitate removal. Regulatory teams should monitor for follow-up communications regarding the root cause of the sterility assurance failure.
Class II. Reason: Lack of Sterility Assurance. Product: Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01. Firm: Reliance Life Sciences Private Limited (Navi Mumbai N/A India). Status: Ongoing.
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