Drug major Cipla Ltd. on Sunday said its subsidiary is voluntarily recalling one lot of medication in the U.S. due to seal integrity issues.
InvaGen Pharmaceuticals Inc., USA, is voluntarily recalling one lot of Vigabatrin for Oral Solution, USP (500 mg), at the consumer level, due to seal integrity issues, allowing for powder leakage from the pouch, the Mumbai-based drug maker said 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 added.
The population at risk is primarily infants and young children, Cipla said.
In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect, such as intoxication or breakthrough seizures, requiring medical intervention, it stated.
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, it said.
The medication is used for the treatment of refractory complex partial seizures, as adjunctive therapy in patients two years of age and older who have responded adequately to several alternative treatments. Vigabatrin for oral solution is not indicated 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 was distributed nationwide to partnered distributors and consignees.
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 added.
