Cipla-led arm recalls one lot of Vigabatrin owing to seal intergrity issue

11 Dec 2023 , 11:43 AM

Cipla, a pharmaceutical company, announced on Sunday that its subsidiary is voluntarily recalling one lot of medicine in the United States owing to seal integrity problems.

According to a regulatory filing, 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 concerns that allow powder leaking from the bag.

An improper pouch seal may cause powder mix to leak outside the pouch, resulting in a reduced amount of medicine inside the pack compared to the label claim and possibly underdosing, it noted.

It noted that in certain individuals, there is a significant possibility that incorrect dose would result in a major adverse impact, such as intoxication or breakthrough seizures, necessitating medical intervention.

A decline in phenytoin blood levels might result in life-threatening seizures for a tiny proportion of individuals who have severe or frequent breakthrough seizures, according to the study.

The medicine is used as supplementary therapy in patients two years of age and older who have reacted effectively to numerous other therapies for refractory complex partial seizures.

According to Cipla, the drug is packed in foil pouches, each containing 500mg of Vigabatrin, and a shelf pack has 50 foil-sealed pouches.

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