After more than a year of near-constant recalls, the folks at Johnson & Johnson’s McNeil Labs aren’t finished yet. This time, it’s a mere 12 million bottles of Motrin that are being recalled from store shelves because the pills may not dissolve as quickly as they are supposed to.
A jury has awarded the family of a child $10 million after she developed skin burns on 85% of her body after taking Children’s Motrin.
Instead of issuing a recall, after Johnson and Johnson discovered its Motrin caplets were defective, they hired a contractor to go around the country buy up all the drugs. It was a “secret recall” that left the bad medicine on shelves for months for consumers to buy. Now the Oregon AG is suing J&J. The story broke when one of the guys hired to do the buying faxed regulators the instructions J&J gave him.
Johnson & Johnson continues to earn its title as the recall king of the over-the-counter drug business with the announcement of three separate recalls totaling around 5 million units of Children’s Benadryl Allergy Fastmelt Tablets, Junior Strength Motrin Caplets, and Extra Strength Rolaids Softchews.
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.
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.
Remember the recalled liquid Tylenol and other children’s medicines last month? Or the stinky drugs that were recalled back in January? Or the children’s Tylenol that was recalled last September? The FDA remembers, which is probably why it’s “conducting a company-wide investigation of McNeil Consumer Healthcare’s drug manufacturing practices to determine whether similar problems exist throughout the company.” Also, a date has now been set (May 27) for the House Committee hearing where the CEO and chairman of parent company Johnson & Johnson are expected to testify.
The House Committee on Oversight and Government Reform — the same crew behind the Toyota recall hearings — has announced that it has opened an investigation into the recent recall of Children’s Tylenol and several other brands of kids’ medicine.
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.
Some batches of a certain type of Tylenol had an unusual moldy, musty, or mildew-like odor that is associated with non-serious nausea, stomach pain, vomiting, or diarrhea. The smell is apparently from a chemical that was on the wood pallets the pills were stored on. Originally, the recall was just for one type of Tylenol. Now there is a big ass list, which includes some types of Motrin, Rolaids and St. Joseph brand products.
A new ad for Celebrex, a prescription painkiller related to Vioxx, has come under fire for implying that Celebrex is as safe as non-prescription painkillers such as ibuprofen (Advil, Motrin) and naproxen (Aleve.) A consumer group has written a letter to the FDA requesting that they ban the ad, claiming that it contains “false or misleading statements.”
“The overall purpose of the ad is to make it appear, contrary to scientific evidence, that the cardiovascular dangers of Celebrex are not greater than those of any of the other Nsaid painkillers,” the letter said, referring to nonsteroidal anti-inflammatory drugs. “Further, it asserts that certain gastrointestinal problems are, if anything, less frequent with Celebrex than with two popular over-the-counter (OTC) painkillers.”
The ad, which is two-and-a-half minutes long (Pfizer was the only sponsor of the program on which it aired), can be viewed at Celebrex.com. The ad marks Celebrex’s return to advertising after a two year hiatus following Vioxx’s withdrawal from the market due to dangerous cardiovascular side-effects.
“Non-prescription pain relievers used by millions of U.S. consumers need stronger health warnings regarding liver or stomach risk, the Food and Drug Administration said Tuesday.” The drugs in questions are acetaminophen (Tylenol), and NSAIDs like ibuprofen (Advil, Motrin). In particular acetaminophen is associated with liver problems.