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Bacteria-Tainted Ingredient Prompts Children’s and Infants’ Tylenol Recall

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More than 20 Children’s and Infants’ Tylenol liquid medicines have been recalled because of possible bacterial contamination.  According to a “Dear Healthcare Professional” letter  issued by McNeil Consumer Healthcare, the bacteria Burkholderia cepacia (B. cepacia) was detected in an “inactive ingredient” in products manufactured between April and June 2008.

According to the letter, the portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product.  As a precautionary measure, McNeil is recalling all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria.  The company is implementing this voluntary recall at the warehouse and retail level, and maintains that Children’s ad Infants’ Tylenol products currently on store shelves meet all specifications.

To determine if a Tylenol product is involved in this recall, consumers can find the lot numbers on the bottom of the box containing the product and also on the sticker that surrounds the product bottle. The full list of affected products is available here.  Consumers with the  affected product can contact McNeil’s  Customer Care Center at 1- 800-962-5357 to obtain a coupon for a new bottle.

The voluntary recall applies only to select lots of Children’s and Infants’ Tylenol liquid products. The recall does not  apply to Children’s Tylenol Meltaways and Junior Strength Tylenol Meltaways.

While ingestion of contaminated  pharmaceutical product is not known to be a route of transmission of B. cepacia infection, infection has been reported following the use of contaminated pharmaceutical products such as mouthwashes and nasal sprays. Adverse health consequence 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 is advising parents and caregivers who have administered affected product to their child or infant and have concerns to contact their healthcare providers.

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