This was successfully posted to your pofile.
This box will close automatically in a few seconds. Close this window
We don't have an e-mail address on file for you. To use AAFP Connection, you must have an e-mail address in our records. Click Here
McNeil Recalls Children's, Infants' Tylenol, Motrin, Benadryl, Zyrtec
Generic Versions of Products Not Affected, Says FDA
By News Staff
A complete list of affected products is included in McNeil's news release.
The company said the products were being recalled because of manufacturing deficiencies that could affect quality, purity or potency. In a May 1 news release, FDA officials said that some of the recalled products may contain higher concentrations of active ingredients than specified, while others contain inactive ingredients that may not meet internal testing requirements. Other products may contain foreign particles.
Generic versions of the products -- acetaminophen (Tylenol), ibuprofen (Motrin), cetirizine (Zyrtec) and diphenhydramine (Benadryl) -- are not affected by the recall and are considered safe to use, the FDA said.
The agency said the potential for serious health problems with use of the recalled products is remote, but FDA officials advised parents and caregivers to not administer the medications to their children as a precaution.
Adverse reactions or quality problems experienced with use of the products can be reported to the FDA's MedWatch program.
Consumers can contact McNeil at (888) 222-6036 or online. The manufacturer is offering consumers with affected products refunds or coupons to use with replacement bottles.
In January, McNeil recalled more than 500 lots of OTC products -- including Benadryl, Rolaids, multiple formulations of both Motrin and Children's Motrin and numerous formulations of Tylenol and Children's Tylenol -- because of chemical contamination.
That recall came on the heels of a September 2009 action, in which the manufacturer recalled more than 50 lots of its liquid children's and infants' Tylenol products because of potential bacterial contamination.
McNeil Recalling Hundreds of Lots of Contaminated OTC Medications
FDA Criticizes Manufacturer for Handling of Investigation
McNeil Recalls Children's, Infants' Tylenol Products
Bacterial Contamination Concerns Spur Action
FDA News Release: "FDA Provides Consumer Advice Following Recall of Products for Infants and Children"
(May 1, 2010)
McNeil Product Recall Information