When Johnson & Johnson announced a recall of 13 million Rolaids last week because of metal and wood particles in the product, the company refused to identify the third party manufacturer that made the product saying their identity was "confidential business information."
In a letter to the FDA today, Congressman Darrell Issa (R-CA) incoming Chairman of the House Oversight and Government Reform Committee, identified the Rolaids manufacturer as BestSweet based in North Carolina.
A spokesperson for BestSweet provided this statement: "We have an excellent safety track record, we are cooperating with all parties."
Issa wrote, "Since BestSweet's...facility produces more than 4 billion products each year, I am concerned about FDA's knowledge of BestSweet's contractual relationship with Johnson & Johnson in manufacturing Rolaids...".
The FDA told CBS News in an email earlier this week that it could not reveal the name of the third party manufacturer because "The identity of a sub-contractor is considered confidential, commercial information, and is not releasable by FDA pursuant to federal law." The FDA has also noted that any manufacturing problems with BestSweet are J&J's responsibility.
J&J told CBS News that they announced the Rolaids recall after receiving almost two dozen complaints from consumers complaining of vomiting, tooth and gum injury and an unusual smell.
The Rolaids recall came on the heels of J&J's ongoing problems with its over-the-counter unit known as McNeil Consumer Healthcare, that began in April 2010 when the company had to recall 136 million bottles of children's cold medicine. The FDA shut down McNeil's Ft. Washington, Pennsylvania plant. Last week, Larry Biegelsen, a Wells Fargo Senior Analyst predicted "a strong likelihood of near-term FDA enforcement action" related to the company's Puerto Rico plant.
The company has had eleven recalls since 2009.