SACRAMENTO, Calif. — Leached pesticides, particles of wood and metal, infectious bacteria, overdosed medicines, underdosed medicines. And, oh yes, that strange moldy and musty scent.
These are the elements of a dramatic spate of recalls plaguing the makers of Tylenol, and keeping store shelves relatively bare of the brand’s once-robust suite of products.
Drugstores, pharmacy sections and supermarkets are running low on Tylenol after years of these recalls, leaving consumers to weather the summer cold season without an abundance of the drug that’s become synonymous with acetaminophen.
Instead, a platoon of private brands have been strategically placed in the pain-relief aisle as stores leap to fill the void with their own products. Sometimes this can make for an irked customer who’s brand-loyal, or who has been told by a doctor to take Tylenol for mild pain and fever.
“They’re a little disappointed,” said Larry Jones, store manager at a Rite Aid drugstore in East Sacramento. “They are not happy about it, but I say, ‘What can you do?’ Then they get mad.”
While offering few details, Tylenol’s makers are vowing to return the company’s products to the shelves as soon as possible. They made a point of noting that the recalls were voluntary, and that none of the recalled drugs had posed serious health risks. But at this point, with millions of vials recalled, the bulk of the Tylenol line is unavailable to consumers.
The story behind the low stocks of Tylenol is also the story of how its maker, Johnson & Johnson, found itself overwhelmed by quality control problems known to the U.S. Food and Drug Administration.
Shelves have been partly or mostly bare of the Tylenol products since 2009, when the FDA pressed the 125-year-old company to start voluntary recalls amid growing complaints about a musty, moldy odor in many Tylenol products.
The FDA lacks the authority to order recalls, but it could threaten court action against pharmaceutical firms if voluntary recalls were not launched.
The troubles began in 2008, when Johnson & Johnson was slow to identify the problem behind the moldy odor, prompting criticism from the FDA.
It turned out to be airborne contamination from a chemical called 2,4,6-Tribromoanisole, a pesticide and wood preservative used to treat wooden pallets. The pallets, at the company’s manufacturing plant in Puerto Rico, held Tylenol packaging materials for storage and transport.
Tylenol containing trace amounts of the pesticide prompted consumer complaints of intestinal problems such as nausea, stomach pain, vomiting and diarrhea.
Under the stern eye of the FDA, the company launched what would be the first of a series of rolling recalls. The primary concern was Tylenol tainted by TBA, but there were also cases of over-the-counter medicines containing minute pieces of wood and metal, a batch of raw materials contaminated by the infectious bacteria burkholderia cepacia, Tylenol formulas for children that were too potent and Motrin tablets that were basically impotent.
There were 26 recalls from 2009 to May 17, 2012, many of them affecting multiple products. Details are posted on the website of McNeil Healthcare LLC, a subsidiary of Johnson & Johnson. None of the recalls involved life-threatening conditions, the FDA and Johnson & Johnson said.
The rolling recalls targeted not just Tylenol but a host of other Johnson & Johnson product lines as well. They included Rolaids, Motrin, Benadryl, Imodium, Sudafed PE, Aveeno, Zyrtec, St. Joseph’s Children’s Aspirin and Simply Sleep brands.
Congressional hearings in 2010 put both FDA officials and Johnson & Johnson executives in the hot seat. The FDA ultimately stepped up its quality-control oversight. Of the four manufacturing facilities making the drugs, three ended up seized by court order by the FDA. The FDA closed down the most problematic plant, in Fort Washington, Pa., and company officials are unable to say when it may reopen.