Drug giant Cipla said on Sunday that its subsidiary has been voluntarily recalling a whole lot of medication in the United States due to issues in seal integrity.

“InvaGen Pharmaceuticals Inc., USA is intentionally recalling a lot of Vigabatrin for Oral Solution USP at a consumer level because of seal integrity issues, which allowed for powder leakage from the medicine pouch,” said the Mumbai-based drug maker in a regulatory filing.

“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 pack compared to the label claim and potential underdosing,” it had added.

The population at risk is primarily infants and young children, Cipla said.

“For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening seizures, requiring immediate emergency room treatment,” it said. “Cipla has so far not received any reports of adverse events related to this recall.”

The medicine is used to cure refractory complex partial seizures as adjunctive treatments in patients of two years of age or older who have responded effectively to other treatment alternatives.

Vigabatrin for oral solutions is not considered as a first-line agent.

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

The affected lot of medicine was distributed throughout the nation to partnered consignees and distributors.

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

“Distributors, retailers, and consumers in possession of the affected batch are advised to initiate the return process through their respective place of purchase,” it further added.

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