FDA: McNeil QA OK'd use of bacteria-tainted ingredients in Tylenol

Add gram-negative bacterial contamination to the list of manufacturing woes cited last week in Johnson & Johnson/McNeil's recall of 1,500 lots of Children's Tylenol and other products. 

Bacterial contamination is missing among the causes initially cited, and it is missing as of midday Wednesday in the recall notice posted on the Tylenol Internet site. That list includes high API concentrations, substandard inactive ingredients and particle contamination, as we reported Tuesday.

Yet reference to the bacterial contamination not only appears first among 20 observations reported by investigators in the 17-page Form 483 filed April 30, 2010, the form says the company knew about the contaminated ingredients and used them anyway.

The QA department did not exercise its responsibility to "reject and withhold from approval any raw material component that contained known contamination of gram-negative organisms," the form reports. "Raw material had known contamination with gram-negative organisms and were approved for use to manufacture several finished lots of Children's and Infant's Tylenol."

The 20 observations reported by investigators fall into four categories: Quality systems, production systems, labeling and packaging, and lab operations.

McNeil says it has shut down the facility and will restart operations only after it has fixed the manufacturing problems. The recalled products are also made at other facilities, the company says, which are still operating.

- here's the Form 483
- see this USA Today coverage