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.
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.
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.
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 word “topical” has a very distinct meaning. That is: “Put this on your skin.” The American people seem to be a bit confused on this point, however, because the FDA has politely reminded us FOR THE LOVE OF GOD STOP DRINKING BENADRYL LOTION.