Tylenol recall 2010 pulls 40 Johnson and Johnson kids medicines
Tylenol recall 2010 involves just one of many drugs taken off the market by a leading American pharmaceutical manufacturer in the largest-ever U.S. recall of childrens’ medicines. Earlier this month, inspectors from the Food and Drug Administration (FDA) shut down the Johnson & Johnson plant where childrens’ Tylenol is made because of quality and safety violations. The FDA is also investigating reports of hundreds of side effects from drugs involved in the recall. The House Committee on Oversight and Government Reform has scheduled a hearing on May 27.
Johnson & Johnson recall list
Tylenol recall 2010 was announced this month by Johnson & Johnson’s McNeil Consumer Healthcare unit. The Wall Street Journal reports that the FDA Johnson & Johnson recall list includes more than 40 types of liquid formulations of infant and children’s Tylenol, Motrin, Zyrtec and Benadryl products because of manufacturing problems. McNeil, whose managers may soon be needing a bad credit personal installment loan, said some products on the Johnson & Johnson recall list had higher concentrations of active ingredient than specified, and some products may contain tiny metallic particles left as a residue from the manufacturing process.
FDA Johnson & Johnson recall
As part the Johnson & Johnson recall investigation, CNNMoney.com reports that the FDA is looking into reports of at least 775 serious side effects from drugs recalled by McNeil. The FDA is also investigating several hundred reports of serious side effects, including seven deaths since May 1, when the FDA Johnson & Johnson McNeil recall was announced. McNeil has maintained that its recall of the children’s drugs was not “undertaken on the basis of adverse medical events” but as a precautionary measure.
McNeil Pharmaceuticals Tylenol
Earlier this month CNNMoney.com reported that the FDA inspection of the McNeil plant in Fort Washington, Penn., revealed that a lack of proper controls in the manufacturing process led to some batches of McNeil Pharmaceuticals Tylenol being “superpotent.” The FDA inspection detailed dusty and filthy conditions at the plant, including “incubators with a large amount of visible gray and brown dust/debris, large holes in the ceiling and thick dust covering the grill inside a filtered cabinet.”
FDA McNeil recall investigation
The FDA’s findings are noted in a congressional report on the FDA McNeil recall investigation reviewed by Portfolio.com. The report said that McNeil failed to follow through after unexplained instances of too much active ingredient in Infant’s Tylenol, putting children at risk of overdosing. The document, prepared for the Thursday hearing of the House Committee on Oversight and Government Reform, paints a picture of McNeil Pharmaceuticals Tylenol executives that had many opportunities to fix manufacturing problems and avoid multiple recalls. Senior officials with Johnson & Johnson and McNeil told the FDA in February they were personally addressing manufacturing issues after FDA recalls in September and November and a government warning in January.
Complaints ignored, no action taken
The document on the FDA Johnson & Johnson McNeil recall also said that McNeil’s September 2009 recall of children’s drugs because of potential bacterial contamination didn’t include all potentially affected lots. McNeil didn’t take corrective action after receiving almost 50 complaints from consumers of foreign material in the company’s products from June 2009 to April 2010. So far, the FDA says it isn’t aware of any children harmed from taking the recalled medicines but it is still investigating reports of illnesses and deaths.