Up to 775 reported complications with recalled children’s medications made by Johnson & Johnson, including 30 deaths, have sparked a US health committee investigation, Reuters reports.
So far, a congressional report says that no direct link has been found between the dozens of recalled J&J medications with the reported health complications.
The recall of J&J medications was announced on April 30, and since then several hundred more cases of complications, and even deaths were reported. At the time, FDA said the chance of getting sick from the products was “remote,” Reuters reports.
The US health committee will hold a hearing on Thursday with FDA and J&J officials to discuss the manufacturing lapses that led to contamination and recall of medications. The recalled products include liquid versions of Tylenol pain reliever for children, the pain medicine Motrin for infants and children, and allergy drugs Benadryl and Zyrtec, as well as other medications.
The overall recall involves about 70% of the OTC market for pediatric liquid medicines. According to some officials it is the “largest recall of children’s medicine in the history of the FDA.”
Following the recall, J&J has shut down the manufacturing of liquid nonprescription medicines at its Fort Washington, PA plant until they get a clearance from the FDA to resume production. For now, they need to deal with quality lapses noted by FDA inspectors, such as bacterial contamination of ingredients and filthy equipment.
Reuters reports that according to the report, the FDA inspectors found that the medications made by McNeil Consumer Healthcare (J&J’s subsidiary) “had the potential to be superpotent.”
