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Major drug recall alert
Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Rolaids Recall
Containers' Moldy Odor to Blame for Recall of 60 Million Over-the-Counter Products
By Daniel J. DeNoon
WebMD Health News
Reviewed by Louise Chang, MD
Jan. 15, 2010 -- Because of a sickening smell in some containers, 54 million packages of 27 different over-the-counter remedies now are being recalled.
Products include various types of child and/or adult Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Rolaids, and Simply Sleep. This adds to the 6 million packages of Tylenol recalled late last year, bringing the total number of recalled products to 60 million.
A musty, moldy odor coming from the products has sickened at least 70 people with nausea, stomach pain, vomiting, and diarrhea. The symptoms go away by themselves and no one has been seriously injured.
The FDA says Johnson & Johnson's McNeil Consumer Health Care knew of the problem for more than a year. When the company did act in November and December 2008, it did too little too late, said Deborah M. Autor, director of the FDA's Office of Compliance.
"When something smells bad, literally or figuratively, companies must aggressively investigate and take all actions necessary to solve the problem," Autor said at a news conference. "McNeil should have acted faster."
The odor comes from a chemical, 2,4,6-tribromoanisole or TBA. TBA is produced when fungi break down a commonly used fungicide called 2,4,6-tribromophenol. The full health effects of TBA are not known.
Before being filled with product, product containers were stored on wooden pallets apparently treated with the fungicide. TBA seems to have infiltrated the product containers before they were filled.
The FDA inspected McNeil's main plant at Las Piedras, Puerto Rico, and was not happy with what it found. The FDA says McNeil began receiving complaints in May 2008, but failed to investigate fully or to warn consumers in a timely manner.
Containers' Moldy Odor to Blame for Recall of 60 Million Over-the-Counter Products
By Daniel J. DeNoon
WebMD Health News
Reviewed by Louise Chang, MD
Jan. 15, 2010 -- Because of a sickening smell in some containers, 54 million packages of 27 different over-the-counter remedies now are being recalled.
Products include various types of child and/or adult Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Rolaids, and Simply Sleep. This adds to the 6 million packages of Tylenol recalled late last year, bringing the total number of recalled products to 60 million.
A musty, moldy odor coming from the products has sickened at least 70 people with nausea, stomach pain, vomiting, and diarrhea. The symptoms go away by themselves and no one has been seriously injured.
The FDA says Johnson & Johnson's McNeil Consumer Health Care knew of the problem for more than a year. When the company did act in November and December 2008, it did too little too late, said Deborah M. Autor, director of the FDA's Office of Compliance.
"When something smells bad, literally or figuratively, companies must aggressively investigate and take all actions necessary to solve the problem," Autor said at a news conference. "McNeil should have acted faster."
The odor comes from a chemical, 2,4,6-tribromoanisole or TBA. TBA is produced when fungi break down a commonly used fungicide called 2,4,6-tribromophenol. The full health effects of TBA are not known.
Before being filled with product, product containers were stored on wooden pallets apparently treated with the fungicide. TBA seems to have infiltrated the product containers before they were filled.
The FDA inspected McNeil's main plant at Las Piedras, Puerto Rico, and was not happy with what it found. The FDA says McNeil began receiving complaints in May 2008, but failed to investigate fully or to warn consumers in a timely manner.