Shilpa Medicare Recalls 27,923 Pemetrexed Chemotherapy Vials in US Over Discoloration
Raichur: Shilpa Medicare initiated a voluntary recall at the retail/hospital level of 27,923 vials of Pemetrexed Injection in the United States of America. The recalled products comprise 9,489 vials of 50 mL and 18,434 vials of 10 mL of Pemetrexed Injection 100 mg/10 mL and 500 mg/50 mL (Pemetri RTU™).
The recall covers four batches, consisting of two batches of each strength of the product. The company stated that the recall was undertaken due to the observation of atypical discoloration of the drug product, which appeared green to dark green.
Shilpa Medicare clarified that this appearance is not consistent with the approved product specification, which defines the appearance of the solution as “clear, colorless to pale yellow to green-yellowish solution.” The recall has been classified by the US Food and Drug Administration (US FDA) as a Class II recall at the hospital level.
The company emphasized that the recall was initiated voluntarily and as a precautionary measure, in consultation with and in accordance with the procedure prescribed by the US FDA. Shilpa Medicare further stated that no adverse event has been reported to the company in relation to the affected batches.
The company also clarified that the recall is confined to the specified batches and does not affect any other product manufactured by the company. It does not impact the company’s manufacturing arrangements or the supply of its products to customers.
Shilpa Medicare stated that it does not foresee any material impact from the recall or from the aforesaid news report on the company’s financial position, operations or other affairs.
