On April 30, McNeil, a unit of Johnson & Johnson (J&J), recalled 43 varieties of Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, and Children’s Benadryl Allergy Liquid in Bottles in the U.S. and 11 other countries. At the time, the company said some drugs might contain a higher concentration of active ingredients than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.
J&J removed the questionable OTC products from store shelves in what Congressional staff described as “the largest <"https://www.yourlawyer.com/topics/overview/Childrens-Tylenol">recall of children’s medicine in the history of the U.S. Food & Drug Administration (FDA),” quoted Reuters from a May 24 memo to committee lawmakers. Now, Reuters reports that the FDA has received over 700 complaints about adverse reactions in children and infants given J&J medications. The reports include 30 deaths. Direct links have not yet been made with to J&J drugs, said Reuters citing a Congressional memo.
Recently, we wrote that the Wall Street Journal obtained a copy of a letter McNeil sent to doctors and poison control centers on May 1 providing information about the recall in which it said that some samples of recalled infants’ Tylenol were found to contain as much as 24% more active ingredient than shown on the label. Also, the Journal recently published new details about McNeil Consumer Healthcare’s recent recall of over-the-counter (OTC) medicines. Much of what the Journal reports is disturbing.
Meanwhile, members of the House Oversight and Government Reform Committee released details of the FDA’s investigation this week and a U.S. House of Representatives hearing to review the manufacturing issues at J&J plants that led to the recall is scheduled for today, said Reuters. The FDA is investigating manufacturing procedures at the Fort Washington, PA manufacturing facility where the recalled medicines were made and is also investigating McNeil’s manufacturing company wide. McNeil also makes drugs at plants in Lancaster, PA, and Las Piedras, Puerto Rico. Since the recall, the Fort Washington plant has been closed until McNeil can assure quality production and the FDA clears the site.
Written testimony, authored by Joshua Sharfstein, the FDA’s principal deputy commissioner and prepared for today’s House committee meeting discussed the broad recall and said the agency is working with the firm “to address its systemic quality issues,†quoted the Journal. “FDA is also considering additional enforcement actions against the company for its pattern of noncompliance which may include seizure, injunction, or criminal penalties,” Mr. Sharfstein said, wrote the Journal. “Over the last several years, FDA has had growing concerns about the quality of the company’s manufacturing process,” Sharfstein added.
According to Reuters, FDA inspectors found a variety of problems at the plant in late April, such as “bacterial contamination of ingredients and filthy equipment … some medications … were overly concentrated and ‘had the potential to be superpotent,’ citing the Congressional memo. The Journal noted that the bacterial contamination was found in a raw ingredient used to manufacturer Tylenol and another problem resulted in some drugs to have higher levels of active ingredients while some products contained metallic particles.
