Cipla's arm InvaGen Pharma USA recalls anti-epileptic drug due to packaging issues

In the past one month, the stock of Cipla has declined by over 1 percent

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26 Aug, 2025 12:21

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Pharma major Cipla's wholly-owned subsidiary InvaGen Pharmaceuticals USA voluntarily recalled one lot of Vigabatrin for oral solution USP - 500 mg to the consumer level due to seal integrity issues that could lead to powder leakage from the pouch.

"An improper seal in the pouch may lead to the leakage of powder blend outside the pouch, resulting in a lower content of medicine inside the pouch compared to the label claim and result in potential underdosing. The population at risk is primarily infants and young children," the exchange filing read on December 10.

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The product is used for the treatment of refractory complex partial seizures as adjunctive therapy in patients 2 years of age and older who have responded adequately to several alternative treatments.

The medication is packaged in foil pouches, each containing 500 mg of Vigabatrin, and there are 50 foil sealed pouches in a shelf pack, the management said.

"The affected lot is NB301030, with an expiration date of March 2025. The Vigabatrin for Oral Solution, USP 500 mg product was distributed nationwide to partnered distributors and consignees," Cipla added.

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InvaGen Pharmaceuticals is notifying the customer level through press releases, letters, telefax, telephone, email, and on-site visits, and is coordinating the return of all recalled products.

In case any adverse reactions or quality problems experienced with the use of this product, Cipla said that the same can be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Till date, Cipla has not received any reports of adverse events related to this recall.

On December 8, the stock of Cipla closed down by 0.3 percent to Rs 1,218 per share. In the past one month, shares of Cipla have declined by over 1 percent as against 4 percent rise in the Nifty Pharma index.

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