Safety alertSource: FDA Drug Enforcement Reports

Class II recall: Shilpa Medicare Limited: PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx

Shilpa Medicare Limited has issued a Class II recall for PEMRYDI RTU (pemetrexed injection), 500 mg/50 mL (10 mg/mL) single-dose vials, NDC 70121-2461-1, manufactured by Zydus Lifesciences and distributed by Amneal Pharmaceuticals. According to the recall notice, the firm received market complaints reporting green to dark green discoloration in certain vials of the solution. The recall record does not specify additional clinical findings beyond the discoloration report.

Most relevant for: patients with cancer receiving pemetrexed chemotherapy treatment

Read the original at FDA Drug Enforcement Reports

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