www.Medtipster.com Source: Wall Street Journal, May 3, 2010
Consumer complaints about certain over-the-counter children’s medications spurred an investigation that led to a recall of more than 40 different products because of manufacturing problems, according to officials at a unit of Johnson & Johnson.
The recall, announced over the weekend by the company and the U.S. Food and Drug Administration, prompted drug stores and other merchants to pull the medicines off their shelves and caused concern among parents who took steps to avoid giving the products — largely pain and allergy remedies — to their children.
A spokesman for J&J’s McNeil Consumer Healthcare unit wasn’t more specific about what issues consumers raised that led to the internal probe.
“We always receive some consumer inquiries about our products and those inquiries led to the investigation that ultimately led to this recall,” the spokesman, Marc Boston, said.
The company said there haven’t been any serious side effects reported, and the company and the FDA said the potential for harm is remote. Still, the company and the agency said the products shouldn’t be given to children for precautionary reasons.
The recall involved at least 1,000 lots of products, including pediatric versions of Tylenol, Motrin, Zyrtec and Benadryl.
Some of the liquid formulations may contain a higher concentration of their active ingredient than they should while others may contain inactive ingredients at inappropriate levels, or tiny metallic particles that are a residue of the manufacturing process, the company said.
The medicines were sold in the U.S. and Canada as well as in countries as far away as Fiji and Kuwait. All were made at a factory in Fort Washington, Pa., the FDA and the company said. Neither the company nor the FDA could say how many bottles of medicine were involved.
At English Drug, an independent pharmacy in Bethel, Conn., staffers removed several products from the store’s shelves Sunday morning after learning about the recall on the Internet. “These are very popular products, but we pulled them” out of safety concerns for consumers, said Denise McMahon, a pharmacist at the store.
In New York City, Natalia Carin said she recently gave her 2-year-old son Cole children’s Zyrtec and Motrin. He appears to be fine, she said, but added, “I’d like some information about what kind of substance this was and how dangerous it might be and what we can expect.”
Kenneth Polin, a pediatrician at Town and Country Pediatrics, with offices in Chicago and its suburbs, had heard from few worried parents Sunday, but says his advice is to turn to generic versions of the medicines. He recommended that before consumers buy a generic, they make sure to ask a pharmacist whether J&J manufactured it.
The recall is another dent in J&J’s reputation as a model of corporate responsiveness. That harks back to the deadly Tylenol poisonings in the early 1980s, when the company reacted swiftly to recall the product and inform the public.
More recently U.S. regulators have criticized J&J’s handling of product-quality issues, because of a widening series of recalls of over-the-counter medicines that accelerated late last year.
In November, the company recalled a limited number of certain bottles of Tylenol arthritis-pain caplets after identifying an uncharacteristic smell or taste associated with the products.
In December, J&J had to expand the recall to include all lots of the product. A month later, J&J widened the recall again to include other brands such as Motrin and Benadryl.
That resulted in the FDA sending J&J a warning letter saying the company had violated good-manufacturing rules at its Las Piedras, Puerto Rico, plant.