New Delhi– Shilpa Medicare Limited has launched a voluntary recall of 27,923 vials of Pemetrexed Injection in the United States after some batches showed atypical discoloration.
According to a stock exchange filing, the recall was initiated July 29 at the retail and hospital level and covers four batches of Pemetrexed Injection 100 mg/10 mL and 500 mg/50 mL, marketed as Pemetri RTU.
Of the affected products, 9,489 are 50 mL vials and 18,434 are 10 mL vials.
The company said the recalled drug showed green to dark green discoloration that did not conform to its approved appearance specifications. The product is supposed to be a clear solution ranging from colorless to pale yellow or green-yellowish.
The U.S. Food and Drug Administration has classified the action as a Class II hospital-level recall.
Shilpa Medicare said it initiated the recall voluntarily as a precautionary measure and in consultation with the FDA. No adverse events have been reported in connection with the affected batches, the company said.
The recall is limited to the four batches and does not affect any of the company’s other products, manufacturing arrangements or supplies to customers.
Shilpa Medicare said it does not expect the recall to have a material impact on its financial position or operations.
The development comes several months after Shilpa Medicare announced a co-development and supply agreement between its wholly owned subsidiary, Shilpa Biologicals Private Ltd., and Finland-based Orion Corporation for an intravenous nivolumab biosimilar intended for the European market.
Under that agreement, Shilpa Biologicals will co-develop, manufacture and exclusively supply the biosimilar from its biologics facility in Dharwad, Karnataka. Orion will hold exclusive rights to register, market, distribute and sell the product across Europe. (Source: IANS)
