FDA report shows quality control issues at medicine manufacturer

Posted on May 05, 2010

Last week, Johnson & Johnson voluntarily recalled over 43 over-the-counter children's medications including Tylenol and Motrin manufactured by their sub-unit, McNeil Consumer Healthcare. 


According to a recently released report by the Federal Drug Administration, federal inspectors had found more than 20 manufacturing problems at a Pennsylvania plant that has since been shut down. 


The report sent from the FDA to McNeil Consumer Healthcare last week prior to the recall showed that the company was using raw materials with known bacterial contamination to make certain lots of infants' and children's liquid Tylenol. However, samples of the finished product tested negative for the bacteria. 


The FDA report also said that the manufacturer had failed to respond properly to several dozen complaints submitted by consumers who had found foreign particles in certain medications.


McNeil Consumer Healthcare has recalled about 1,500 product lots this week, the fifth recall of their products since last September.