UAE Recalls Tylenol Drug

The Ministry of Health on Saturday ordered a recall of over-the-counter pain and fever relief drug Tylenol due to a musty odour that has made people in the US sick. The move followed US Food and Drug Authority’s (FDA) alert issued on Friday in three countries — the UAE, America and Fiji.

The ministry also advised people who may have already bought the drug to check the company website for the affected batch number and in case of a match, return it to the respective pharmacy. Several people in the US complained of non-serious sickness including nausea, stomach pain, vomiting and diarrhoea.

McNeil Consumer Healthcare, a unit of J&J, pulled 500 lots of Rolaids, Motrin, children’s Tylenol, regular, extra-strength and eight-hour Tylenol, Benadryl, St. Joseph’s Aspirin and Simply Sleep caplets in America, the United Arab Emirates and Fiji.

The recall in the UAE includes some batches of regular and extra-strength. Tylenol, children’s Tylenol and Tylenol arthritis are available in the form of drops, caplets, suppositories and syrup.

“All private and government health establishments in the country, including hospitals and pharmacies have been asked to return the affected batch to the agent after company tests found the product unsuitable for use,” said Dr Amin Al Amiri, CEO Medical Practice and License at the UAE health ministry.

McNeil said it was voluntarily recalling about 500 lots of the product. McNeil said an investigation had shown the odour is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole.

“This can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials. The health effects of this chemical have not been well studied but no serious events have been documented.”

“This is a voluntary recall by the company after it found that the cap had caused an odour in the bottled medicine. This caused dizziness after use but no such case has been reported in the UAE,” Al Amiri said.

Deborah Autor, director of FDA’s compliance office on drugs, said on Friday that the agency had warned McNeil that it had mishandled the problem.

Share/Save