Johnson & Johnson continues to have troubles with its pharmaceutical plant in Puerto Rico, where subsidiary McNeil Consumer Healthcare had to recall millions of bottles of Tylenol, Motrin and other products in January. The latest bad news for Johnson & Johnson came from the Food and Drug Administration after inspectors found numerous problems with the Puerto Rican operation.

 

Among the violations the FDA cited the company for were shipping drugs that failed quality requirements, failing to identify product defects during routine testing, failing to detect incorrect expiration dates on drug labels, failing to adequately investigate product problems, failing to follow laboratory controls, and inadequate training of lab staff.

 

In addition to the January recall, Johnson & Johnson in April recalled about 136 million bottles of liquid children’s Tylenol and other pediatric products made at a plant in Pennsylvania.

-Noel Brinkerhoff

 

Drug Maker Cited on Quality Issues (by Natasha Singer, New York Times)

Inspection Report (Department of Health and Human Services) (pdf)

FDA Investigates Contamination at Johnson & Johnson Plant Making Children’s Tylenol and Motrin (by David Wallechinsky, AllGov)