Cipla’s wholly-owned subsidiary -- InvaGen Pharmaceuticals USA has voluntarily recalled one lot of Vigabatrin for oral solution USP - 500 mg to the consumer level due to seal integrity issues that could lead to 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. Cipla has not received any reports of adverse events related to this recall. The affected lot is NB301030, with an expiration date of March 2025.
Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1675.20 |
| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
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