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Bacterial Contamination Prompts Recall of Children’s and Infants’ Tylenol

September 24, 2009

In consultation with the Food and Drug Administration (FDA), McNeil Consumer Healthcare is voluntarily initiating a recall of certain lots of Children's and Infants' Tylenol® liquid products.

The  product website www.tylenol.com states the recall is due to an unused portion of one inactive ingredient did not meet all quality standards, but a letter to healthcare professionals details the recall is attributed to a bacteria, Burkholderia cepacia (B. cepacia), detected in bulk raw material. Although the portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product, all product that utilized any of the raw material manufactured during that time period is recalled as a precaution. McNeil claims bacteria have not been detected in finished product and the finished product has met all specifications.

Ingestion of contaminated pharmaceutical product is not known to be a route of transmission of B. cepacia infection, but infection has been reported following the use of contaminated pharmaceutical products such as mouthwashes and nasal sprays. Adverse health consequences of B. cepacia infections could be potentially severe especially in high-risk patients, such as those with underlying pulmonary disease, cystic fibrosis or compromised immune systems.

McNeil Consumer Healthcare advises concerned parents and caregivers who have administered affected product to their child or infant to contact their healthcare providers or call McNeil's consumer call center at 1-800-962-5357.

The recalled products were manufactured between April 2008 and June 2008. Consumers can find the lot numbers on the bottom of the box containing the liquid product and on the sticker surrounding the product bottle. For recalled product description and lot number list, please click here: http://www.tylenol.com/generic.jhtml?id=tylenol/news/subpchildinfantnews.inc.

The recall does not apply to Children's TYLENOL® Meltaways and Junior Strength TYLENOL® Meltaways, which were the subject of a 2005 Food and Drug Administration (FDA) alert due to confusing packaging that could lead to children getting the wrong dose, including a possible overdose.

If your child, a child in your family or anyone you know have used any of these recalled Tylenol products and suffered adverse reactions as a result, please contact the attorneys here at Napoli Bern Ripka Law Firm LLP. Our law firm has helped so many people who have become victims of recalled medications. The consultation is free; just call 1-888-529-4669