New Delhi, Aug 18 (IANS) Drug firm Shilpa Medicare Limited on Tuesday has initiated a voluntary recall of 27,923 vials of Pemetrexed Injection 100 mg/10 mL and 500 mg/50 mL (Pemetri RTU) in the United States due to atypical discolouration of the drug product.
According to a stock exchange filing, the company initiated the recall on July 29, 2026, at the retail and hospital level. The recall covers four batches, comprising two batches of each strength. Of the total affected quantity, 9,489 are 50 mL vials and 18,434 are 10 mL vials.
The company said the affected product showed green to dark green discolouration, which is not consistent with its approved appearance specification. The approved specification describes the drug as a clear, colourless to pale yellow to green-yellowish solution.
The US Food and Drug Administration (US FDA) has classified the action as a Class II hospital-level recall.
Shilpa Medicare said the recall was initiated voluntarily as a precautionary measure, in consultation with and in accordance with the procedure prescribed by the US FDA. The company added that no adverse event had been reported in connection with the affected batches.
The recall is limited to the four affected batches and does not impact any other products of the company, its manufacturing arrangements or the supply of its products to customers.
Shilpa Medicare also said it does not expect the recall to have any material impact on its financial position, operations or other affairs.
The development comes a few months after the company announced a co-development and supply agreement between its wholly-owned subsidiary, Shilpa Biologicals Private Ltd (SBPL), and Finland-based Orion Corporation for an intravenous nivolumab biosimilar for the European market.
Under the agreement, SBPL will co-develop, manufacture and exclusively supply the biosimilar from its biologics facility in Dharwad, Karnataka. Orion will have exclusive rights to register, market, distribute and sell the product across Europe.
–IANS
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