InvaGen Pharmaceuticals is recalling one lot, NB301030, of Vigabatrin for Oral Solution, USP, 500 mg, because it has been found to have seal integrity issues allowing for 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. 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. 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. The Vigabatrin for Oral Solution USP, 500 mg product was distributed nationwide.
To date, Cipla has not received any reports of adverse events related to this recall.
BACKGROUND: The product being recalled is used for the treatment of refractory complex partial seizures as adjunctive therapy in patients 2 years of age and older who have inadequately responded to several alternative treatments. Vigabatrin for oral solution is not indicated as a first-line agent.
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