With the health of kids in mind, the Congressional Committee on Oversight and Government Reform recently summoned William Weldon, the CEO of pharmaceutical colossus Johnson & Johnson, to testify about a massive recall of children’s medicines. The company, together with its manufacturing unit McNeil Consumer Healthcare, had removed more than 135 million units of child-strength Tylenol, Benadryl and Motrin from store shelves in order to investigate them for bacterial contamination or the presence of small metal parts.

Though federal regulators said the pills posed only a remote potential for danger to children, lawmakers were more concerned about the “phantom” nature of the recall.

Ordinarily, says Donald Aday, an expert in the field of product recalls, “once a company determines that a drug product has to be recalled from the market, the proper procedure is to first notify the FDA that the product will be removed from store shelves, distribution centers, warehouses and anywhere else in the supply chain.” That didn’t happen in this case.

Instead, J&J sent teams of third-party subcontractors into stores to secretly buy up all affected Motrin products for children. This wasn’t technically illegal, because the federal Food and Drug Administration can’t force a company to undertake a recall. But, says Aday, reporting rules are very strict, and it is “good business practice for the manufacturer to then alert the public through a press release that such a recall is taking place.”

Neither J&J nor McNeil ever issued such a release, leaving parents in the dark as to the safety of the medicines they were giving their children.

Compounding the children-related problem, federal authorities uncovered another phantom recall in June 2009, when McNeil secretly tried to remove more than 88,000 defective Motrin tablets for adults. In all, say investigators, Johnson & Johnson engaged in a half-dozen clandestine recalls involving at least three third-party vendors specializing in this type of work. Questioned about the practice, a former employee of such a firm said it was “out of the ordinary” for the client to withhold knowledge of their activities from the public.

Coming in the wake of recalls of drugs such as Avandia and medical products such as DePuy hip implants, the J&J case is fueling concern among consumers about dangerous prescriptions and medical devices. Anyone worried about injuries from defective products should contact a lawyer experienced in handling product liability cases.


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