Cipla US arm recalls Vigabatrin for Oral Solution, USP 500mg over pouch leakage issues
Cipla has not received any reports of adverse events related to this recall.;
Hauppauge: Cipla Limited has announced that its wholly-owned subsidiary, InvaGen Pharmaceuticals Inc., USA is voluntarily recalling one lot of Vigabatrin for Oral Solution, USP 500mg, to the consumer level. Vigabatrin for Oral Solution, USP 500 mg 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 lifethreatening seizures requiring immediate emergency room treatment," the release stated.
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