Cipla subsidiary InvaGen issued a voluntary recall of one lot of the oral anti-seizure drug vigabatrin due to problems with seal integrity in its packaging.
The recalled lot of the medication, which is typically used to treat infantile spasms and refractory complex partial seizures, is NB301030 with an expiration date of March 2025. The medicine was distributed nationwide in the U.S.
In a notice posted on the FDA website, the company said a faulty seal in the pouch could lead to the powder leaking from the pouch, plus the potential for patients to be underdosed.
“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,” the company said. “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.”
To date, Cipla said there have been no reports of adverse events related to the recall.
Just two weeks ago, Cipla was slammed with a warning letter that outlined a number of ongoing issues with the company’s manufacturing facility in Pithampur, India, which was the target of a Form 483 earlier this year. In its warning letter, the regulatory agency cited three major failures that led to other problems at the facility, which was inspected between February 6 and February 17 of this year.