Pharmaceutical company Pendopharm, in consultation with Health Canada, has announced the voluntary recall of two lots of the ACET-650 acetaminophen suppository (DIN 02230437) due to dosage mislabeling on the blister packs inside the box.
Some of the suppositories in the affected lots containing 650mg may be wrongly labeled as 325mg on the blister packs. The external box specifies the correct dose 650mg.
There is a possibility of overdosing due to the labeling error, which is expected to lead to liver failure or death.
ACET-650 is an over-the-counter acetaminophen suppository indicated for relief of mild to moderate pain, and to reduce fever.
Canada-based Pendopharm is a division of Pharmascience.