Daniel J. DeNoon
January 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.
The FDA has given McNeil 15 days to respond to its seven-point warning letter. In addition to the contamination issue, the FDA says there are product-quality issues with some Motrin products.
Specific products included in the recall include:
Children's Motrin
Children's Tylenol
Extra Strength Tylenol
Regular Strength Tylenol
Tylenol 8 Hour
Tylenol Arthritis
Tylenol PM
Benadryl
Motrin IB
Rolaids
Simply Sleep
St. Joseph Aspirin
A complete list of the recalled products, including package sizes, product types, lot numbers, and UPC codes, can be seen at www.mcneilproductrecall.com. Consumers with question can call McNeil at 888-222-6036.
Consumers who think they may have suffered ill effects from the products should contact the FDA at www.FDA.gov/medwatch.
SOURCES:
FDA news conference with Deborah M. Autor, director, Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), FDA; Jason Woo, MD, associate director for medical and scientific affairs, OC, CDER, FDA, and Karen Hirshfield, acting branch chief, Recalls and Shortages Branch, OC, CDER, FDA.
PR Newswire, Jan. 15, 2009
News release, J&J McNeil Consumer Healthcare.
FDA warning letter to McNeil, Jan. 8, 2009.
Marc Boston, spokesman, McNeil Consumer Healthcare.
January 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.
The FDA has given McNeil 15 days to respond to its seven-point warning letter. In addition to the contamination issue, the FDA says there are product-quality issues with some Motrin products.
Specific products included in the recall include:
Children's Motrin
Children's Tylenol
Extra Strength Tylenol
Regular Strength Tylenol
Tylenol 8 Hour
Tylenol Arthritis
Tylenol PM
Benadryl
Motrin IB
Rolaids
Simply Sleep
St. Joseph Aspirin
A complete list of the recalled products, including package sizes, product types, lot numbers, and UPC codes, can be seen at www.mcneilproductrecall.com. Consumers with question can call McNeil at 888-222-6036.
Consumers who think they may have suffered ill effects from the products should contact the FDA at www.FDA.gov/medwatch.
SOURCES:
FDA news conference with Deborah M. Autor, director, Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), FDA; Jason Woo, MD, associate director for medical and scientific affairs, OC, CDER, FDA, and Karen Hirshfield, acting branch chief, Recalls and Shortages Branch, OC, CDER, FDA.
PR Newswire, Jan. 15, 2009
News release, J&J McNeil Consumer Healthcare.
FDA warning letter to McNeil, Jan. 8, 2009.
Marc Boston, spokesman, McNeil Consumer Healthcare.
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