For the second time this year -- and the third time in less than nine months -- McNeil Consumer Healthcare is recalling children's and infants' liquid pain relief products.
The manufacturer said in an April 30 news release(www.fda.gov) that it is recalling all lots that have not yet expired of certain brand-name OTC children's and infants' liquid medications, including more than 40 variations of Tylenol, Motrin, Zyrtec and Benadryl products.
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(www.fda.gov), 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(www.fda.gov).
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.