A major recall of children’s medications in Canada, the United States and several other countries is raising concerns over manufacturing processes used by the company at the centre of the recall. It also highlights significant differences in how the recall is being handled by authorities in the United States and Canada.
McNeil Consumer Healthcare issued a recall over the weekend of more than 40 types of infants’ and children’s over-the-counter liquid medication sold in more than 10 countries. The Canadian branch of the company posted a recall alert marked “urgent” on its website telling consumers to discontinue use of 11 children’s and infants’ products. There are 10 Motrin brand liquid products involved in the recall as well as one Tylenol product.
McNeil Consumer Healthcare Canada
Specifically, the products may contain particulate matter, spokeswoman Tina Peyregatt said. In some instances, the particulate matter may be some of the product itself that has solidified.
“In other cases, it may be residue from the manufacturing process,” she said.
Ms. Peyregatt said in a telephone interview she didn’t know what type of residue was involved and is trying to get that information. She added that tests indicate the particulate matter is non-toxic in the doses that may be present in the recalled products. None of the products pose a safety threat to Canadians, she said.
But in the United States, the company said the recalled products may contain tiny metallic particles that are a residue of the manufacturing process. Some products recalled in that country may also contain higher amounts of active ingredients or other dosing problems, but those issues don’t affect any Canadian products, Ms. Peyregatt said.
This is the second major recall involving the company in recent months and adds to concerns about the company’s practices.
In January, McNeil Consumer Healthcare recalled dozens of products sold under the Tylenol, Motrin, Benadryl, Rolaids and St. Joseph brands, an expansion of an earlier recall involving arthritis medications. In Canada, the recall was limited to certain Rolaids products. The recall was initiated after consumer reports that products had a mouldy, musty or mildew-like odour that may have been linked to some cases of nausea, stomach pain, vomiting and diarrhea.
The company said the problem was caused by a manufacturing issue, specifically, the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials used in the products.
But it was also revealed that the company didn’t initiate a recall until 20 months after first receiving reports from consumers over mouldy-smelling products, news that fuelled concerns about the company.
The latest recall may add to consumer questions about product quality.
“It does raise some alarms,” said Mary Wiktorowicz
Dr. Wiktorowicz said she has a five-year-old, and had some of the recalled product in her home. She said she found it difficult to get information from the company and that it should do a better job of communicating the problem and the risks.
At the same time, the recall prompted starkly different responses from authorities in the United States and Canada.
The U.S. Food and Drug Administration issued a safety alert about the recall just after midnight on Saturday and posted information on its website. The FDA also announced that it is launching an investigation into the company’s products and facilities.
The commissioner of food and drugs, Margaret Hamburg, warned consumers in an FDA news release not to use the affected products and said the agency will be investigating because Americans “deserve medications that are safe, effective and of the highest quality.”
By contrast, Health Canada has yet to issue a recall advisory or press release that addresses the McNeil Consumer Healthcare recall.
Ms. Peyregatt said the recall was done through consultation with Health Canada and that the department is aware of it.
Health Canada said in a statement yesterday that, in this case, the company is responsible for communicating the recall to the public. It’s also looking into compliance reports to assess the practices and procedures at the U.S. plant where the recalled medication was made.
Bruce Cran, president of the Consumers’ Association of Canada
“We’re still following rather than leading and we’re still very reliant on what the FDA does,” Mr. Cran said. ”I think parents should be concerned.”
For more information about the recall and which products are included, please see: mcneilcanada.com
