Leached pesticides, particles of wood and metal, infectiousbacteria, overdosed medicines, underdosed medicines. And, oh yes,that strange moldy and musty scent. These are the elements of a spate of recalls plaguing the makers ofTylenol and keeping store shelves relatively bare of the brand'sonce-robust suite of products. Drugstores, pharmacy sections and supermarkets in the Sacramentoregion are running low on Tylenol after about three years of theserecalls, leaving consumers to weather their colds without anabundance of the drug that's become synonymous with acetaminophen.
A platoon of other brands has been placed in pain-relief aisles asstores leap to fill the void with their own labels. Sometimes, this can make for an irked customer who's brand-nameloyal, or told by a doctor to take Tylenol for mild pain and fever. "They're a little disappointed," said Larry Jones, store manager atthe Rite Aid on J Street in east Sacramento. "They are not happyabout it, but I say, 'What can you do?' Then they get mad." While offering few details, Tylenol's makers vow to return thecompany's products to store shelves as soon as possible.
They madea point of noting that the recalls were voluntary and that none ofthe recalled drugs had posed serious health risks. But at this point, with millions of vials recalled, the bulk of theTylenol line is unavailable to consumers. The story behind the low stocks of Tylenol is also the story of howits maker, Johnson & Johnson, found itself overwhelmed byquality-control problems known to the U.S. Food and DrugAdministration. Shelves have been partly or mostly bare of Tylenol products since2009, when the FDA pressed the 125-year-old company to startvoluntary recalls amid growing complaints about a musty, moldy odorin many Tylenol products. Anti-mosquito Patch
The FDA lacks the authority to order mandatory recalls outright,but it could threaten court action against pharmaceutical firms ifvoluntary recalls were not launched. The troubles began a year earlier, in 2008, when Johnson & Johnsonwas slow to identify the problem behind the moldy odor, promptingcriticism from the FDA. According to congressional testimony by FDA officials, it turnedout to be airborne contamination from a chemical called2,4,6-Tribromoanisole, or TBA, a pesticide and wood preservativeused to treat wooden pallets. The pallets, at the company'smanufacturing plant in Puerto Rico, held Tylenol packagingmaterials for storage and transport. Tylenol containing trace amounts of the pesticide prompted consumercomplaints of intestinal problems such as nausea, stomach pain,vomiting and diarrhea. China Alkaline Water Purifier
Under the stern eye of the FDA, the firm launched what would be thefirst of a series of rolling recalls. The primary concern wasTylenol tainted by TBA, but there were also cases ofover-the-counter medicines containing minute pieces of wood andmetal, a batch of the medicine's raw materials contaminated by theinfectious bacteria Burkholderia cepacia , Tylenol formulas for children that were too potent and Motrintablets that were basically impotent, according to congessionaltestimony. There were 26 recalls from 2009 to as recently as May 17, many ofthem affecting multiple products. Details are posted on the website of McNeil Healthcare LLC, asubsidiary of Johnson & Johnson. None of the recalls involvedlife-threatening conditions, the FDA and Johnson & Johnson said. Alkaline Water Flask Manufacturer
The rolling recalls targeted not just Tylenol but a host of otherJohnson & Johnson/McNeil product lines, as well. They includedRolaids, Motrin, Benadryl, Imodium, Sudafed PE, Aveeno, Zyrtec andSimply Sleep brands. Congressional hearings in 2010 put FDA officials and Johnson &Johnson executives in the hot seat. The FDA ultimately stepped upits oversight of quality control. Of the four manufacturingfacilities making the drugs, three ended up seized under courtorder by the FDA.
The FDA closed down the most problematic plant,in Fort Washington, Pa., and company officials are unable to saywhen it may reopen. All of this explains why, today, pain-relief aisles are bereft ofthe once-ubiquitous family of Tylenol brands
A platoon of other brands has been placed in pain-relief aisles asstores leap to fill the void with their own labels. Sometimes, this can make for an irked customer who's brand-nameloyal, or told by a doctor to take Tylenol for mild pain and fever. "They're a little disappointed," said Larry Jones, store manager atthe Rite Aid on J Street in east Sacramento. "They are not happyabout it, but I say, 'What can you do?' Then they get mad." While offering few details, Tylenol's makers vow to return thecompany's products to store shelves as soon as possible.
They madea point of noting that the recalls were voluntary and that none ofthe recalled drugs had posed serious health risks. But at this point, with millions of vials recalled, the bulk of theTylenol line is unavailable to consumers. The story behind the low stocks of Tylenol is also the story of howits maker, Johnson & Johnson, found itself overwhelmed byquality-control problems known to the U.S. Food and DrugAdministration. Shelves have been partly or mostly bare of Tylenol products since2009, when the FDA pressed the 125-year-old company to startvoluntary recalls amid growing complaints about a musty, moldy odorin many Tylenol products. Anti-mosquito Patch
The FDA lacks the authority to order mandatory recalls outright,but it could threaten court action against pharmaceutical firms ifvoluntary recalls were not launched. The troubles began a year earlier, in 2008, when Johnson & Johnsonwas slow to identify the problem behind the moldy odor, promptingcriticism from the FDA. According to congressional testimony by FDA officials, it turnedout to be airborne contamination from a chemical called2,4,6-Tribromoanisole, or TBA, a pesticide and wood preservativeused to treat wooden pallets. The pallets, at the company'smanufacturing plant in Puerto Rico, held Tylenol packagingmaterials for storage and transport. Tylenol containing trace amounts of the pesticide prompted consumercomplaints of intestinal problems such as nausea, stomach pain,vomiting and diarrhea. China Alkaline Water Purifier
Under the stern eye of the FDA, the firm launched what would be thefirst of a series of rolling recalls. The primary concern wasTylenol tainted by TBA, but there were also cases ofover-the-counter medicines containing minute pieces of wood andmetal, a batch of the medicine's raw materials contaminated by theinfectious bacteria Burkholderia cepacia , Tylenol formulas for children that were too potent and Motrintablets that were basically impotent, according to congessionaltestimony. There were 26 recalls from 2009 to as recently as May 17, many ofthem affecting multiple products. Details are posted on the website of McNeil Healthcare LLC, asubsidiary of Johnson & Johnson. None of the recalls involvedlife-threatening conditions, the FDA and Johnson & Johnson said. Alkaline Water Flask Manufacturer
The rolling recalls targeted not just Tylenol but a host of otherJohnson & Johnson/McNeil product lines, as well. They includedRolaids, Motrin, Benadryl, Imodium, Sudafed PE, Aveeno, Zyrtec andSimply Sleep brands. Congressional hearings in 2010 put FDA officials and Johnson &Johnson executives in the hot seat. The FDA ultimately stepped upits oversight of quality control. Of the four manufacturingfacilities making the drugs, three ended up seized under courtorder by the FDA.
The FDA closed down the most problematic plant,in Fort Washington, Pa., and company officials are unable to saywhen it may reopen. All of this explains why, today, pain-relief aisles are bereft ofthe once-ubiquitous family of Tylenol brands