Children's Tylenol & other meds recalled!
The Food and Drug Administration continues to investigate McNeil-PPC's voluntary recall of Children's Tylenol liquid and other liquid children's medicines, but has not indicated whether further action will follow in the wake of the late April 2010 recall.
FDA spokeswoman Elaine Bobo told Reuters Monday that it is too early to tell whether further action is warranted against McNeil parent Johnson & Johnson and that the agency is still gathering information.
* Pharmacists Recommend Generics After Latest Tylenol Recall
The FDA asked the J&J unit to issue the recall Friday morning after a routine inspection of McNeil's U.S. manufacturing plant in Fort Washington, Pa. The recall, which McNeil issued that evening, affects more than 1,500 lots of some 40 different liquid children's medicines. Bobo said that it is not clear exactly how many bottles of product are subject to the recall.
While the FDA still says that there is only a remote health risk from using the affected products, McNeil advises consumers not to give their children the affected medicines, and the FDA could still implement stronger enforcement actions, such as a consent decree, if it deems J&J's response to the recall inadequate.
The recall is the fourth product recall McNeil has issued in the past year and the second major recall issued in 2010. In January, the company recalled several hundred lots of a number of adult and children's medicines, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol, after consumers reported moldy smells coming from the pills that were manufactured at a plant in Puerto Rico; some cases of nausea, stomach pain, vomiting and diarrhea were associated with the recalled products.