Recall after mislabelling of Medline Industries’ drugs
pharmafile | October 20, 2015 | News story | Manufacturing and Production | US, acetaminophen, paracetamol, product recall
Medline Industries is voluntarily carrying out a nationwide recall of the painkiller acetaminophen, due to a labelling error on the packaging.
The 500mg, uncoated compressed acetaminophen (paracetamol) tablets, are in bottles that are marked with the wrong strength, creating the danger that consumers could take too much – posing a potential risk of liver damage.
Illinois-based Medline Industries says the acetaminophen 500mg tablet has been found to be mislabelled, instead displaying acetaminophen 325mg on the bottle.
The error cannot be easily identified by the user or prescriber. And although there have been no adverse reports from taking the medication, if the product is taken at the maximum labelled dose, every four hours, five doses a day, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure.
The lot that is being recalled was distributed between June 12, 2015 and Sepember18, 2015 with the expiration date of May 2018.
Acetaminophen tablets are an over the counter (OTC) oral medication used to temporarily relieve minor aches and pains due to minor pain of arthritis, muscular aches, back aches, headaches, toothaches, the common cold, premenstrual and menstrual cramps, and reduces fever.
This medication is packaged as 100 tablets per bottle and is a non-aspirin pain reliever which can be found in more than 600 over-the-counter products.
In the past other companies have been forced to recall the drug. This includes GlaxoSmithKline, who voluntarily recalled four lots of its Panadol containing acetaminophen in Puerto Rico after the bottles did not have child-resistant packaging.
And Johnson & Johnson also had issues after they found that a Janssen unit in South Korea sold Tylenol for children that may have contained more amounts of acetaminophen than what was on the label.
Yasmita Kumar
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