In a shocking revelation, The Wall Street Journal is reporting that the bacterial contamination responsible in part for the May 2010 Children’s Tylenol, Motrin, Zyrtec and Benadryl recall had been detected as early as the summer of 2009. The bacteria were found to be present in a raw ingredient used to make Children’s Tylenol and other medications. The information comes from a congressional memo that was prepared by Democratic staff members for the House Committee on Oversight and Government Reform’s hearing to be held on Thursday, May 27, 2010. The hearing has been called to address the recent recall of Children’s Tylenol, Motrin, Zyrtec, and Benadryl. Johnson & Johnson and the FDA will send representatives to testify before the Congressional panel.
The September 2009 Recall
McNeil Consumer Healthcare, a division of Johnson & Johnson, recalled 50 lots of children’s Tylenol medications in September 2009. The reason given for that recall was that an inactive ingredient used in the production of the medications “did not meet quality standards.” According to the congressional memo, the ingredient was later found to contain bacterial contamination from B.cepacia which is known to be antibiotic resistant. The memo also reveals that the September 2009 recall of Children’s Tylenol did not include all lots that could have been contaminated by B.cepacia.
The May 2010 Recall
According to the FDA, the most recent Children’s Tylenol, Motrin, Zyrtec, Benadryl recall was due to bacterial contamination of one of the raw ingredients used in the production of the medications. The bacteria they found was B.cepacia, the same bacteria present in 2009. There has been no evidence of bacteria in any of the Children’s Tylenol, Motrin, Zyrtec, or Benadryl medications that reached consumers. FDA spokesperson Elaine Bobo stated, “There is no reason for a consumer scare.” She further explained that the FDA hasn’t found any link between the recalled Children’s Tylenol, Motrin, Zyrtec, and Benadryl products and serious health problems. However, she did acknowledge that “McNeil’s facility has some serious product quality manufacturing issues.”
McNeill’s Multi-Faceted Problems
Bacterial contamination is not the only problem plaguing McNeil Consumer Healthcare or Johnson & Johnson. The most recent Children’s Tylenol, Motrin, Zyrtec, Benadryl recall was also prompted by higher than specified drug concentrations and tiny particles in some of the medications. It has been reported that drug concentrations were up to 24% higher than specified on Children’s Tylenol, Motrin, Zyrtec, and Benadryl medication labels. The congressional memo revealed that McNeil took no action after discovering there was too much of the active ingredient (drug) in Infant’s Tylenol. This put infants at risk of drug overdose. The tiny particles were later found to be metallic in nature. The particles were reported to have been a “residue from the manufacturing process.” How the particles got into the medications is not known, but FDA inspections have shown unsanitary conditions at the McNeil Fort Washington, Pennsylvania plant.
The McNeil facility at Fort Washington has been shut down since April 26. It is unclear why bacterial contamination was so rampant in the plant, why drug concentrations were allowed to be much higher than specified, or how metallic particles found their way into the medications.
According to the congressional memo, the FDA has received several hundred consumer complaints, including that of 30 deaths possibly related to Tylenol products. Seven of the deaths have occurred since May 1. However, none of these involved any children. All this points to serious problems with maintaining standards of purity, potency, and quality at McNeil Consumer Healthcare. Johnson & Johnson has released a statement saying they are, “taking steps to bring its operation back to a level of quality that Johnson & Johnson demands of its companies.”
The congressional memo raises some troubling questions. Why were consumer complaints ignored? Why was no action taken? Why was the recall characterized as a “precautionary measure” when bacteria and higher concentrations of drugs were found to be present?” Hopefully these questions will be asked and answered during the House Committee on Oversight and Government Reform’s hearing on Thursday.
For More Information About the Tylenol 2010 Recall See the Following Articles:
Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall 2010: Congressional Panel to Investigate Recall of Children’s Medications
Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall 2010: How to Request a Refund from McNeil Consumer Healthcare
Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall 2010 Expanded
The Wall Street Journal