According to the company’s press release, published on Friday last week, unit-of-use blister packs may contain 100 mg product instead of 200 mg product.
While the blister cards within the pack are properly labeled as 100 mg ODT, the plastic shell pack containing the 100 mg blister cards is labeled as 200 mg ODT, according to Impax.
“Shell-packs from the affected lot may contain 100 mg ODT instead of 200 mg ODT, and as a result, it is possible that consumers could take less than their intended lamotrigine dose,” the press release said. “A reduction in dose may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms.”
Impax has faced several issues in the past. As In-PharmaTechnologist.com previously reported, the company settled a lawsuit in September 2014 over allegations related to manufacturing issues for $8m.
According to the company’s SEC filing at the time, it settled in order “to eliminate the uncertainty, distraction, burden and expense of further litigation.”
Prior to the lawsuit, Impax had hired specialists to help sort out its manufacturing issues.
Impax did not respond to a request for comment at that time and could not be reached today.