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KT Archives: UAE Recalls Tainted Tylenol

DUBAI - 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.

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by

Asma Ali Zain

Published: Sat 1 May 2010, 4:15 PM

Last updated: Mon 6 Apr 2015, 3:34 PM

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.

Customers asked to return affected Tylenol
Consumers who have bought over-the-counter pain relief drug Tylenol have been asked to return the medicine, affected by a particular chemical which gives it a ‘mouldy odour’.

It has also been reported to have caused ‘non-serious’ sickness in people in the US, to the respective pharmacy and claim a safer replacement.

While no such complaint has been received in the UAE, the Ministry of Health on Saturday ordered a recall of the widely used pain and fever relief drug after the US Food and Drug Authority (FDA) issued an alert on Friday in three countries namely the UAE, America and Fiji.

A statement issued by Johnson & Johnson Middle East on Monday said that the affected batches in the UAE included only two products — Tylenol arthritis and Tylenol extra that were marketed in the country in mid 2009. The company also clarified that no children’s drug has been affected as 
 suggested by the UAE Ministry of Health earlier.

“Consumers can return the affected batches to their pharmacy and will receive non-affected stocks of the same product in return. The company will exchange all recalled stocks, including those returned by consumers that have been partially consumed,” read the statement. The statement also added that the company recall was precautionary and voluntary.

Several people in the US complained of a ‘non-serious’ sickness including nausea, stomach pain, vomiting and diarrhoea after consuming the medicine. However, no such complaint was received in the UAE.

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

“All private and government health establishments in the country, including hospitals and pharmacies have been asked to return the affected batches to the agent after company tests found the product unsuitable for use,” Dr Amin Al Amiri, CEO Medical Practice and Licence at the UAE health ministry had earlier told Khaleej Times. In case of additional inquiries or to report any adverse reactions, consumers can alert the department of registration and control of medicines in Abu Dhabi on the following numbers: 02-6117318 or 02-6117391 or check the website http://www.mcneilproductrecall.com/ .

Asma Ali Zain

Published: Sat 1 May 2010, 4:15 PM

Last updated: Mon 6 Apr 2015, 3:34 PM

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