- Shilpa Medicare recalled 27,923 vials of Pemetrexed Injection in the US due to discoloration
- Recall includes four batches with 9,489 vials of 500 mg and 18,434 vials of 100 mg strengths
- FDA classified the recall as Class II, indicating low risk of serious health harm
Shilpa Medicare Ltd. has voluntarily recalled 27,923 vials of its chemotherapy drug Pemetrexed Injection in the US after certain batches showed an unusual green to dark-green discolouration.
The recall covers four batches of Pemetri RTU, with 9,489 vials of the 500 mg/50 mL strength and 18,434 vials of the 100 mg/10 mL strength affected, according to an exchange filing.
The recall follows market complaints about the colour of the injectable drug. Under approved specifications, the solution is expected to be clear and colourless to pale yellow or green-yellowish.
The reported green to dark-green appearance therefore prompted the company to take corrective action.
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The US Food and Drug Administration has classified the recall as Class II, a category generally used when exposure to a violative product could cause temporary or medically reversible health consequences, although the probability of serious harm is considered remote.
Shilpa Medicare initiated the recall voluntarily in consultation with the US FDA. Importantly, the company said no adverse events have been reported in connection with the affected batches.
The recall is also limited to the specified batches and does not affect the company's other products, manufacturing operations or supply chain, according to the company's regulatory disclosure.
The affected product, Pemetrexed Injection, is a chemotherapy medicine used in the treatment of certain cancers. Shilpa Medicare's portfolio includes Pemetrexed products for the US and other regulated markets.
For investors, the company has indicated that it does not expect the recall to have a material impact on its financial position or operations. The disclosure came after reports of the US recall and was made to keep shareholders informed.
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