FDA Investigates Contamination at Johnson & Johnson Plant Making Children’s Tylenol and Motrin

Friday, May 07, 2010

The maker of children’s Tylenol and other pediatric medicines has gotten into trouble with federal regulators for operating a plant where materials were contaminated with bacteria and that lacked sufficient quality controls. McNeil Consumer Healthcare, a division of Johnson & Johnson, also was faulted for not addressing nearly 50 consumer complaints about drugs containing black particles.

Inspectors with the U.S. Food and Drug Administration spent ten days going over McNeil’s plant in Pennsylvania, which is the only manufacturer of children’s and infants’ Tylenol, Motrin and other popular over-the-counter remedies.
The FDA’s findings prompted the Johnson & Johnson subsidiary to voluntarily recall 43 medicines in the United States, its territories and nine other countries.
-David Wallechinsky
Inspection Report (U.S. Food and Drug Administration) (pdf)


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