Impax Laboratories has again been tripped up by labeling issues on a drug and is retrieving a lot of a med for treating epilepsy or bipolar disorders in its most recent recall.
The Hayward, CA-based drugmaker has issued a recall for one lot of lamotrigine orally disintegrating tablets in the 200 mg dose because the blister packs might contain 100 mg tablets instead, which means patients might not get their full dose.
Impax ($IPXL) said in a recall letter that each blister card within the unit-of-use blister pack is properly labeled as 100 mg ODT, but that the plastic shell pack containing the 100 mg blister cards is labeled as 200 mg ODT. It said shell packs from the affected lot may contain 100 mg tablets instead of 200 mg tablets.
This is the second recall in recent months that Impax has made because of labeling issues. The earlier recall was for 21 lots, affecting more than 35 million capsules of fenofibrate, a drug to help lower high cholesterol and triglycerides in the blood. In that recall, the FDA reported that the packages might have incorrect or missing lot numbers or expiration dates.
- here’s the release