Medline recalls mislabelled paracetamol
The privately-owned Illinois manufacturer distributed its 500mg uncoated compressed tablets in “Acetaminophen 325mg” packaging between June 12 and September 18, 2015.
“This error is not easily identifiable by the user or prescriber,” said the US FDA.
“If the product is taken at the maximum labeled dose, every four hours, five doses a day, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure.”
The over-the-counter drug is packaged in bottles of 100 pills.
Medline has received no adverse event reports associated with the tablets so far. The company said it is investigating the root cause of the mislabelling and “corrective and preventative actions.” It has notified distributors and retail customers by mail.
