Fears that children’s liquid medication could contain small metal particles is what prompted a major recall in Canada last weekend, according to a company official in the U.S. who said while the risk to consumers is remote, it does exist.
This comes after the Canadian branch of McNeil Consumer Healthcare, the company at the centre of the recall, said it didn’t know the identity of the substance, but that it posed no risk to consumers. The products were pulled off of Canadian shelves because they didn’t meet the “manufacturing specification,” similar to what would happen if there was a printing error on product labels, said company spokeswoman Tina Peyregatt.
“I mean, there’s no safety concern, but it’s not to the quality, the level of quality, that we adhere to, so we pull it off the shelf,” Ms. Peyregatt said in an interview Monday.
As information emerges about the serious nature of problems at the plant where the recalled medication was made and U.S. lawmakers prepare to investigate McNeil, the company’s response to the issue in Canada and lack of involvement from this country’s health regulator raises questions about the level of transparency and consumer protection available this side of the border.
McNeil Consumer Healthcare announced a recall last weekend of more than 40 types of infant’s and children’s over-the-counter liquid medication sold in more than 10 countries. In Canada, the recall is limited to 10 Motrin products and one Tylenol product.
On Monday, McNeil Consumer Healthcare Canada said the recall was being done over concern two types of “particulate matter” may be in the products. In some instances, some of the product’s ingredients may have become solidified in the bottle, Ms. Peyregatt said. In other cases, she said there may be a “residue from a manufacturing process,” but that she didn’t know what the substance was.
“Obviously that becomes very complex and scientific,” Ms. Peyregatt said.
When asked if the residue could be metal particles, as was being reported in the U.S., she said “I have not confirmed metal. I have said residue from a manufacturing process,” and emphasized the mystery substance posed no health risk.
But Marc Boston, a McNeil company spokesman based in the U.S., confirmed Thursday the “residue” in question is indeed tiny metal particles. They pose a remote risk to consumers and the company is advising parents to discontinue use of the products, and seek advice from a health professional if they have any concerns.
In a subsequent interview, Ms. Peyregatt clarified her position to say that while the company knew tiny metal particles may have contaminated Canadian product, no tests have found any type of particulate matter in products sold in this country.
The Canadian branch of McNeil also said Monday that problems with the products came to light after “some excessive quality assurance testing,” according to Ms. Peyregatt. But in fact, the recall was announced after officials from the U.S. Food and Drug Administration inspected the plant in Fort Washington, Pa. where the medications were produced.
The inspection report, which was posted on the FDA’s website a few days ago, highlights numerous problems found at the plant, such as dust and debris. But it also states the company used ingredients it knew were contaminated with bacteria to make finished products, and that the company failed to follow up on dozens of consumer complaints about “foreign materials, black or dark specks” in products from June 2009 to April 2010.
Ms. Peyregatt did not provide the number of complaints the company has received in the past from Canadian consumers about any of the products affected by the recall.
The company’s Fort Washington plant has temporary suspended production to address the issues. Now, a U.S. Congressional committee has launched an investigation into the problem.
But in this country, Health Canada has not issued a warning about the products to parents, saying instead that it has left the responsibility with McNeil to communicate the recall to wholesalers, distributors and retailers who stock the product. After The Globe and Mail published a story on Tuesday about Health Canada’s silence on the issue, the department issued an advisory stating officials had assessed the affected products, that they agree with the FDA’s statements about the recall and will take action if the company didn’t comply with Canadian standards.
Liberal health critic Carolyn Bennett said Health Canada’s response doesn’t indicate the government is taking the issue seriously, a problem she said reflects a lack of leadership in the department.
“It is extremely disappointing,” she said. “They have an opportunity and an obligation to be the communicator in terms of the health and safety of Canadians.”
