A contract manufacturer is likely to blame for the wood and metal particles that consumers are finding in J&J/McNeil's Rolaids. So says the drugmaker in a recall notice posted Thursday on the Rolaids website.
McNeil says its investigation points to the unnamed contractor, but stops short of a conclusion. The investigation continues. In the meantime, McNeil has recalled the affected products and suspended production until it resolves the matter.
Contractor involvement won't lessen the regulatory sting from the recall. Recent FDA warning letters have gone into detail on the brand-holder/contractor relationship: "You are ultimately responsible for the quality of your products," the FDA writes in a warning letter to River's Edge Pharmaceuticals in Suwanee, GA, as reported. "Regardless of who manufactures your products or the agreements in place, you are required to ensure that these products meet predefined specifications prior to distribution."
At 13 million packages, the Rolaids recall is small potatoes for McNeil, which surely has mastered the drill. Its 136-million-bottle recall of liquid children's Tylenol and related products, for example, is but one of its recent mega-volume callbacks.
The recall may well renew calls for a consent decree, as well as bring unwelcome Congressional attention to both the company and the FDA.