Leached pesticides, particles of wood and metal, infectious bacteria, overdosed medicines, under-dosed medicines. And, oh yes, that strange moldy and musty scent.
These are the elements of a spate of recalls plaguing the makers of Tylenol and keeping store shelves relatively bare of the brand's once-robust suite of products.
About three years of these recalls have left consumers to weather their colds without an abundance of the drug that's become synonymous with acetaminophen.
"They're a little disappointed," said Larry Jones, store manager at a Sacramento, Calif., Rite Aid store. "They are not happy about it, but I say, 'What can you do?'"
Tylenol's makers vow to return the company's products to store shelves as soon as possible, and note that the recalls were voluntary and none of the recalled drugs posed serious health risks.
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, which in 2009, pressed the 125-year-old company to start voluntary recalls amid growing complaints about a musty, moldy odor in many Tylenol products.
The troubles began a year earlier, in 2008, when Johnson & Johnson was slow to identify the problem behind the moldy odor, prompting criticism from the FDA.
According to congressional testimony by FDA officials, it turned out to be airborne contamination from a chemical called 2,4,6-Tribromoanisole, or TBA, 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.
Tylenol containing trace amounts of the pesticide prompted consumer complaints of intestinal problems such as nausea, stomach pain, vomiting and diarrhea.
The firm launched 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 the medicine's raw materials contaminated by the infectious bacteria Burkholderia cepacia, Tylenol formulas for children that were too potent and Motrin tablets that were basically impotent, according to congressional testimony.
There were 26 recalls from 2009 to as recently as May 17, many of them affecting multiple products.
The rolling recalls targeted not just Tylenol but also a host of other Johnson & Johnson/McNeil product lines. They included Rolaids, Motrin, Benadryl, Imodium, Sudafed PE, Aveeno, Zyrtec and Simply Sleep brands.
The FDA stepped up its oversight of quality control. Of the four manufacturing facilities making the drugs, three ended up seized under court order by the FDA. The FDA closed down the most problematic plant, in Fort Washington, Pa., and company officials can't say when it may reopen.
All of this explains why, today, pain-relief aisles are bereft of the once-ubiquitous family of Tylenol brands.
But if you ask your pharmacist, store manager or attendant what's behind the shortage, you can pretty much count on getting a general, rather than specific, answer.
"They don't tell us anything except there's a recall and to take the products off the shelves," said Rite Aid's Jones. "Then we get no shipments for months."
Doctors still advise patients to take Tylenol, perhaps meaning that any similar acetaminophen product will do. Patients, consumers and caregivers still go in search of the brand name.
Now, the company that 30 years ago famously survived a cluster of cyanide poisonings in a Chicago tampering case faces an even greater marketing challenge. After three years of erratic or halted product shipments, Johnson & Johnson may have permanently lost some customers to the cheaper store labels.
"They say the consumer is a fickle animal," said Herman Saftlas, a pharmaceutical stock analyst for Standard & Poors Capital IQ. "If they leave the product and are happy with the replacement, they may not come back."
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