Johnson and Johnson, FDA Testify on Phantom Recall Mistake

There is much back and forth today about who knew what, when about the "phantom recall" of Motrin caplets organized by Johnson & Johnson subsidiary McNeil sometime in June of 2009. Emails have surfaced that seem to indicate the FDA did have notice that rather than doing a full recall, J&J had hired a third party company to have contractors walk into stores across the country and simply buy up all the affected Motrin they could find.

ABC News reports that some emails from the FDA in the San Juan, Puerto Rico district seemed to indicate the FDA knew of McNeil's plan to do a Motrin buy-back. Previously, the FDA had claimed not to know about the so-called phantom recall. ABC reports it had obtained documents that show McNeil execs were pleased at gaining FDA acceptance for the recall. One email from McNeil employees began, "Good news," the FDA director in San Juan, "is in agreement with continuing to pull product from the rest of the stores and NOT consider this a National Recall."

J&J is pressing the advantage this type of email has given them. In a statement the company said, "McNeil kept the FDA informed of its actions and removed the product from the market in a compliant manner. However, given the concerns highlighted by the congressional committee with respect to Motrin, moving forward we would like to handle things differently."

Additional email communications make it clear that McNeil executives were charged with coordinating the phantom recall. When J&J discovered that some of the Motrin tables were not dissolving properly, despite the lack of danger to the public, a recall would have been the proper way to proceed. However, as ABC reports, instead of announcing yet another recall, contractors were sent to 5,000 convenience stores around the United States to buy back the defective Motrin without alerting the public.

J&J products have been the subject of eight recalls in the past year. Medicines including Children's Tylenol, Motrin Infant Drops, Children's Benadryl and Zyrtec have all been pulled from the shelves.

The FDA said today that when they learned of the McNeil's phantom recall, they told J&J to go ahead with a full recall before the buy-back program ended. The company agreed to begin a valid recall in July, 2009.

Related Resources:

• J&J, FDA leaders take heat for 'phantom' recall (AP)
• Drugs and Medical Device Recalls (FindLaw)
• J&J Now Faces Lawsuit over Tylenol Recall (FindLaw's Common Law)
• The FDA Criticizes Johnson & Johnson Recall (FindLaw's Common Law)