McNeil said initially that it was recalling "all lots that have not yet expired" of pediatric formulations of four brands: Tylenol, Motrin, Benadryl, and Zyrtec.
But how much was that? At a hearing June 1, Towns said his staff had been told that the recall involved six million bottles of infant and children's medicines. But in testimony that day, an FDA official said the recall covered 136 million bottles.
The company's explanation? A simple misunderstanding.
"The numbers responded to two different questions," said McNeil spokeswoman Bonnie Jacobs. McNeil was recalling six million bottles from stores, and 136 million bottles already in consumers' hands. The total: 142 million bottles.
Then there was the so-called "phantom recall." According to documents obtained by the committee, McNeil's current problems with actual recalls were preceded by a non-recall recall of adult versions of Motrin that did not dissolve properly.
Although the FDA eventually insisted on a formal recall of the Motrin, a brand version of ibuprofen sold in eight-tablet vials, McNeil began with an unusual first step. Instead of a recall, it turned to a contractor that specializes in "reverse logistics" and directed it to go to about 4,500 stores to buy back the suspect product.
"You should simply 'act' like a regular customer while making these purchases," according to one document disclosed at the June 1 hearing. "THERE MUST BE NO MENTION OF THIS BEING A RECALL OF THE PRODUCT!"
In a statement Friday, Jacobs sought to distance McNeil from the document, which she said "did not come from McNeil. It was created by a subcontractor with whom McNeil had no direct contact."
The statement also challenged the significance of the decision to pull back the product:
