Improper Seal Leads Cipla to Recall Vigabratrin

Cipla’s subsidiary, InvaGen Pharmaceuticals, recalling one lot of vigabatrin for oral solution 500 mg, which is used as an added therapy to treat patients two and older who have refractory complex partial seizures The company found seal integrity issues allowing for powder leakage from the pouch. This can lead to potential underdosing.

The population at risk is young children, and inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention. 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. Cipla has not received any reports of adverse events related to this recall.

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 affected lot is NB301030, with an expiration date of March 2025. The NDC number is 6909-7964-53; it was distributed nationwide to partnered distributors.