Following the third recall of Tylenol products in less than a year, the FDA has expanded its investigation into Children’s Tylenol, Motrin, Zyrtec, and Benadryl medications in order to clarify information regarding the possible contamination of the medications with bacteria. Previously, an antibiotic resistant bacteria, Burkholderia Cepacia was found in Children’s Tylenol. The bacteria can cause chronic lung disease.
The recall of Children’s Tylenol, Motrin, Zyrtec, and Benadryl now includes 40 medications in 12 countries including the United States and Canada. In Canada, the recall is limited to Children’s Tylenol Cough & Runny Nose liquid suspension, Children’s Motrin and infants Motrin liquid suspension. For a complete listing of all recalled products in the United States see Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall 2010 Expanded.
The recall is also being investigated by the House Oversight and Government Reform Committee. What has spurred the House Oversight Committee to action? The fact that this latest recall involves children’s medications seems to be the important element in the Committee becoming involved. The frequency of Tylenol recalls also played a role. Over the last 12 months, Tylenol products have been recalled on three separate occasions demonstrating a pattern of problems with quality control of the products. The House investigation was also launched to try and clear up conflicting information given by McNeil Consumer Healthcare and the FDA regarding the nature of the recall. The groups are at odds about what prompted the recall and just how serious it may be to consumers.
The Oversight Committee is also investigating the FDA’s inspection procedures to see if an inadequacy on their part could be a contributing factor to the increase in Tylenol recalls over the past 12 months. There is further concern over the FDA’s characterization of the recall as precautionary. The Oversight Committee is also questioning if McNeil failed to respond adequately to consumer complaints that could have identified a contamination problem much sooner than the May 1, 2010 official recall by the company.
Oversight Committee chairman Edolphus Towns explained in a press release that the Committee “wants to bring attention to the recall particularly due to the fact that children could be adversely impacted if they were to take any of the medicine covered by the recall. When a recall of this nature occurs, it is our responsibility to bring attention to the issue as a public service and to fulfill our oversight responsibility by asking tough questions about the conditions of the manufacturing plant and controls put in place by the drug company’s management, and about whether FDA’s inspection and recall procedures were sufficient.”
In the days ahead, the Committee will be meeting with both McNeil Consumer Healthcare and the FDA for further explanation. Chairman Towns fully expects that a hearing will follow in the coming weeks.”This is an issue we cannot afford to ignore,” stated Towns.
For More Information About the Tylenol Recall See the Following Articles:
Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall 2010 Expanded
Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall 2010: How to Request a Refund from McNeil Consumer Healthcare
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