Nearly five years after McNeil Consumer Healthcare – a subsidiary of Johnson & Johnson – began recalling over-the-counter Infant’s and Children’s Tylenol and Children’s Motrin, the company has acknowledged that it knowingly sold the cold medication that contained metal particles and agreed to pay $25 million to resolve the case. [More]
The fifth recall of a Tylenol product this year is “Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps.” McNeil, a division of Johnson & Johnson, a family company, said the caps had “slightly higher than expected” levels of chlorpheniramine ammonio acetate (CPAA). The recall encompasses roughly 2.5 million packages.
Following a slew of recalls that seemed to have pulled just about every Tylenol product from store shelves, three Johnson & Johnson plants responsible for the recalled goods are being put under the supervision of the FDA.
The new year isn’t starting well for Johnson & Johnson. First, the OTC drug giant gets sued by the state of Oregon over allegations of a phantom Motrin recall. And now its McNeil Labs division has issued the latest in a lengthy list of actual recalls. This time, it’s for certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol upper respiratory products, Benadryl, Sudafed PE, and Sinutab products distributed in the United States, the Caribbean, and Brazil.
The only thing more certain than stinky Tylenol this year is that there would be a lawsuit from consumers at some point, and now it’s happened. Five times, in fact. They’ve been filed against Johnson & Johnson’s McNeil Consumer Healthcare unit and seek class action status, and accuse J&J/McNeil of failing to properly recall the bad drugs and of failing to adequately compensate consumers.
That stink coming from your medicine cabinet may just be Tylenol, Motrin or Benadryl, according to the latest recall from Johnson & Johnson. The company is recalling 21 additional lots of drugs, including batches of Tylenol, Children’s Tylenol, Benadryl and Motrin. The company says “the risk of adverse medical events is remote.”
Should Tylenol have been recalled sooner? FDA inspection reports going back to 2003 paint a queasy picture.
Oopsy-poopsies! Johnson and Johnson forgot to recall four “lots” of Benadryl Allergy Ultratabs and one lot of Extra Strength Tylenol Rapid Release Gels along with the dozens already recalled in Jan. J&J took the pills off the market after consumers complained they smelled moldy and in a few cases, caused vomiting and diarrhea.
Ever since the FDA and Congress started asking Johnson & Johnson to explain why it keeps recalling medicine, there have been references to an unpublicized “recall” that happened in November 2008. Last month, at a hearing of the House Oversight and Government Reform Committee, a J&J executive swore that the company didn’t mean to mislead anyone. It turns out that wasn’t exactly accurate: Bloomberg has obtained emails from J&J’s company, McNeil Consumer Healthcare, that show executives knew the secret recall would trigger an FDA reaction if the agency got wind of its full scope.
Blacksmith Brands bought the PediaCare line of children’s cough and cold medicines from Johnson & Johnson last November. Unfortunately, the company hadn’t switched production over to a different facility, so last Friday it had to recall nearly 100,000 bottles that are guilty by association. There have been no complaints so far about the products, but when your manufacturer is under investigation by the FDA’s criminal division you tend to want to play it safe.
The manufacturing plant that has been the cause of Johnson & Johnson’s latest in a string of recalls has already been described as dirty and poorly maintained. It turns out that it was also staffed with temps and contract employees who weren’t properly trained, according to tax records and an FDA inspection report filed earlier this year.
CNN is reporting that the FDA has referred the Tylenol recall case to their criminal division for investigation. At issue is a pattern of non-compliance with FDA warnings and failures by management of McNeil to investigate and provide a timely resolution to serious problems with the product. These problems include excess amounts of the active ingredient in Tylenol, acetaminophen.
One of the implied promises of a brand name, especially when it comes to drugs, is you can expect higher quality, but maybe that doesn’t apply when it comes to McNeil products.The FDA says the plant that produced the recently recalled children’s Tylenol, Motrin, Zyrtec and Benadryl, was using raw materials that were contaminated with bacteria. The plant also lacked adequate quality-control procedures and was dirty. So far none of the recalled medicine has tested positive for bacterial contamination, but the FDA report suggests that the contaminated material was used to make the recalled lots. The plant has been shut down indefinitely.
The FDA is @#$%# pissed off at McNeil, the company that makes smelly, barfy Tylenol and other products, because apparently this problem has been going on since 2008.