Yesterday, US House Oversight and Government Reform Committee Chairman Edolphus Towns sent a letter to Blacksmith Brands (Tarrytown, NY), a provider of over-the-counter drug and healthcare products, questioning the company’s chairman and CEO about the circumstances of its May 28 voluntary recall of four types of pediatric medications. Blacksmith’s recalled PediaCare products were manufactured at the same Johnson & Johnson/McNeil Consumer Healthcare plant at Fort Washington, Pennsylvania, that has been shuttered since the company’s April 30 recalls.

Towns’s letter requested certain records from Blacksmith to assist in the Committee’s investigation of J&J’s recall. Specifically, Blacksmith was asked to provide, by June 10, 2010:

• Any knowledge of a defect or contamination of any of its products produced at the Fort Washington plant
• Any reports of adverse events from the recalled products
• Copies of all records relating to the May 28 recall, including all communications between the company and J&J, McNeil, and FDA.

Blacksmith said in its recall notice that it was taking this precautionary step because of the manufacturing issues at the McNeil plant. There have been no consumer complaints about the PediaCare products, according to the recall notice.

“Phantom Recall”

In his closing statement at last Thursday’s hearing on J&J’s recent recall of more than 40 of its infants’ and children’s products, Towns expressed his dissatisfaction with the testimony provided by J&J. He said, “I was hoping that J&J would be completely forthcoming today, but I think there are still unanswered questions.” Most notable among his concerns was the issue of the “phantom recall” that came to light during the hearing.

Yesterday, Towns requested records of J&J’s 2008 recall of certain adult Motrin products. The Committee is questioning whether J&J tried to quietly remove the Motrin from store shelves through the use of contractors before it initiated a formal recall of the products. The so-called “phantom recall” involves internal documents revealed at the hearing that instructed employees of a third-party contractor to purchase the recalled products at retail stores, keep detailed records of what products came from where, and to not utter the word “recall.” One particular document instructs employees: “You should simply ‘act’ like a regular customer while making these purchases. THERE MUST BE NO MENTION OF THIS BEING A RECALL OF THE PRODUCT!” Towns said that the company officially recalled the products only after FDA “caught Johnson and Johnson in the midst of the phantom recall.”

For this reason, Towns is requesting further documentation from J&J about this particular recall.

J&J said that the contractors purchased the Motrin to see if a recall would be necessary, according to a Reuters report. The company’s blog, JNJ BTW, has yet to address the issue of the phantom recall. Last Thursday, a post containing the prepared testimony of the company’s representative, Colleen Goggins, went up on the blog, and no posts have been filed since.

Towns concluded his closing statement last week by saying FDA needs more power over recalls: “One thing we know now is that the FDA needs mandatory recall authority. They shouldn’t have to persuade a company to recall suspect products. I intend to introduce legislation to give FDA that authority. FDA should also have the power to order a halt in drug production.”
Read more about FDA’s testimony in today’s ePT story, “FDA Testifies to Congress Regarding J&J Recalls, Quality Concerns.”

[orig. published June 3, 2010]