Children's Tylenol Recall: Did 'Culture of Mediocrity' at McNeil Labs Affect Children's Medicines?

"No, I cannot say that with complete certainty," Sharfstein replied. But he added that no injuries or deaths have been attributed to any of the recalled medicines.

'Culture of Mediocrity' at McNeil?

One member of the committee said McNeil was guilty of a "culture of mediocrity." Another called it a "sloppy shop."

FDA inspectors in late April cited McNeil's Fort Washington, Pennsylvania, plant for a variety of lapses that included bacterial contamination of ingredients, filthy equipment and the potential for medicines to be too potent.

One incident occurred as long ago as November 2008, when McNeil uncovered problems with an adult version of Motrin. Chairman Towns produced documents alleging McNeil told the FDA it wanted to sample the affected Motrin already at retailers. But outside contractors it hired instead bought up the products in question and were told to act like customers and not to mention a recall, according to lawmakers and the FDA. After the agency found out, McNeil recalled the product.

Goggins denied the company tried to avoid a recall by buying up the product and said the FDA was aware of McNeil's actions. Nonetheless, Rep. Towns found "unanswered questions here that are very troubling."

Goggins acknowledged, "The entire episode is extremely embarrassing."

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