Shilpa Medicare recalled 4 pemetrexed injection batches in US on Jul 29
This story was originally published at 18:37 IST on 18 August 2026
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--Shilpa Medicare: Recalled 4 batches of pemetrexed injection Jul 29
--Shilpa Medicare: Recalled batches of pemetrexed on discoloration of drug
MUMBAI – Shilpa Medicare Ltd. Tuesday said it had recalled four batches of pemetrexed injection in the US on Jul. 29, with two batches each of 100 mg/10 ml and 500 mg/50 ml. The batches were recalled due to an "atyipcal" discolouration of the drug, described as green to dark green in appearance, the company said in an exchange filing. The company recalled 27,923 vials of the said injection.
"This observation is not consistent with the approved specification for appearance, defined as "clear, colorless to pale yellow to greenyellowish solution". The recall has been classified by the US FDA (US Food and Drug Administration) as a Class II (hospital level) recall," the company said. The recall was voluntary and out of caution and no adverse event has been reported yet for the affected batches.
The recall is confined to these batches and does not affect any other product, its manufacturing arrangements, or the supply of its products to customers. The company also does not see any material impact of this on its financials.
Tuesday, shares of Shilpa Medicare ended flat at INR 809.80 on the National Stock Exchange. For the June quarter, the company reported a consolidated net profit of INR 1.01 billion on revenues of INR 4.66 billion. End
Reported by Ashutosh Pati
Edited by Deepshikha Bhardwaj
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