A massive Johnson & Johnson recall of over-the-counter drugs including pain relievers Tylenol, Motrin and St Joseph, a children's aspirin, was extended to the United Arab Emirates (UAE) after a warning from the U.S. drug agency, a local business journal reported Sunday.
McNeil Consumer Healthcare, a unit of the U.S. pharmaceutical giant J&J, said it was voluntarily recalling some 500 batches of the products from the UAE, the Americas and Fiji after customers reported an "unusual, moldy" odor that had been linked to gastrointestinal disorders, including stomach pain, nausea and diarrhoea, according to Arabian Business.
Consumers who have an item on the recall list have been urged to stop using the product and contact the company for a refund, the report said.
The drugmaker said it believed that the smell was related to a chemical on wood pallets used to transport and store product packaging material.
"The health effects of this chemical have not been well-studied, but no serious events have been documented in the medical literature," the company was quoted as saying in a statement.
It will stop using the pallets to ship products with the same chemicals, it added.
The recall followed a "warning letter" from the U.S. Food and Drug Administration (FDA) Friday, which accused the firm of failing to investigate the contamination of some of its popular over-the-counter drugs. The FDA said McNeil knew of the problem inearly 2008 but made only limited inquiries.
The move expanded an earlier recall of the Tylenol arthritis pill that was initiated in December last year after customers reported an unusual smell emanating from the products, Arabian Business said.