FDA ALERT: Recall on 21 Pediatric TYLENOL Products

McNeil Consumer Healthcare, the manufacturer of Tylenol products announced yesterday (September 24), that it detected bacteria in an inactive ingredient utilized in the production of several pediatric Tylenol products.  In consultation with the Food and Drug Administration, the company has issued a voluntary recall of 21 chidren’s and infants’ Tylenol products that were manufactured between April 2008 and June 2008.

Although literature suggests that the risk of an infection is low upon the ingestion of a contaminated pharmaceutical product due to the fact that stomach enzymes are usually able to neutralize bacteria, concern remains for those patients who may have lung disease, cystic fibrosis, or perhaps a weak immune system.

For those who may have concerns or questions regarding this issue, McNeil Healthcare has provided a contact number.  They can be reached at 1-800-962-5237 (M-F, 8 am to 8 pm Eastern Time).  The full list of the recalled products and their lot numbers can be accessed at the following site (Lot numbers can be found at the bottom of the packages that contain liquid formulations, and on stickers that surround product bottles):

TYLENOL RECALLED PRODUCTS FULL LIST AND LOT NUMBERS

As an important aside, most individuals appear to be unaware of safety measures that have been published by the U.S. FDA for the use of Tylenol (generically known as ACITAMINOPHEN) - both for pediatric and for adult use.  Due to the widespread reports of liver failure and/or liver damage associated with improper (or excess) Acitaminophen use, these guidelines are important to know.  As this topic is fairly extensive, I shall be writing on this important subject shortly in an upcoming post.  Until then, please pass on this post to those who have children and to others who may have need for this information.