Cipla subsidiary InvaGen Pharmaceuticals has issued a voluntary recall of a single lot of its refractory complex partial seizure (CPS) treatment, Vigabatrin for oral solution, USP 500mg, due to leaking sachets.
The consumer-level recall comes after the company found seal integrity issues that led to powder leakage from the drug sachets.
The product is sold in foil pouches with each sachet containing a 500mg dose of Vigabatrin. Each shelf pack holds 50 pouches.
The oral therapy is an adjunctive treatment for refractory CPS patients aged two years and above with sufficient response to substitute therapies and is not intended as a first-line treatment.
The impacted lot with sealing issues is NB301030. Its expiry date is March 2025.
In a stock exchange filing, Cipla stated: “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.
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“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.”
In patients with severe or repeated breakthrough seizures, a decline in phenytoin blood levels could lead to fatal seizures.
Up to the recall, Cipla noted that the company had not received any reports on adverse events linked to the product.
The US Food and Drug Administration was notified of the recall. InvaGen is informing customers via phone calls, letters, faxes, emails and on-site visits.
The recall comes after the regulatory agency issued a warning letter to Cipla following several complaints linked to defective products in recent years.
