The product is being voluntarily recalled because of powder leakage due to seal integrity issues.
FDA announced on Dec. 11, 2023 that InvaGen Pharmaceuticals, a wholly-owned subsidiary of Cipla Limited, was voluntarily recalling one lot of Vigabatrin for Oral Solution, USP 500 mg. The recall comes after it was found that the product had seal integrity problems resulting in powder leakage from the pouch. Vigabatrin for Oral Solution, USP 500 mg is an adjunctive therapy for the treatment of refractory complex partial seizures in patients two years of age and olderwho have responded adequately to alternative treatments; it is not a first-line agent.
According to FDA, improper sealing of the pouch may cause powder blend to leak outside the pouch, resulting in lower product content than what is listed on the label and, possibly, underdosing. “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,” according to a press release.
The recalled product is packaged in foil pouches with 50 foil-sealed pouches in a shelf pack. The affected lot is NB301030, with an expiration date of 03/2025, and was distributed nationwide to partnered distributors and consignees.
Cipla has stated that it has not received any reports of adverse events related to the recall. Adverse events may be reported to FDA via its MedWatch Event Reporting Program.
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