Tylenol Quality Issues Give McNeil A Headache

FDA finds several serious deficiencies at Puerto Rico facility. Recall expands.

McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, has expanded an earlier US recall of TYLENOL® Arthritis Pain 100 count with EZ-OPEN CAP to include a wider range of over-the-counter products distributed in the Americas, the United Arab Emirates, and Fiji.

The broadened recall includes selected production lots of:

• Children's Motrin - Caplets and Chewables
• Children's Tylenol - Meltaways
• Benadryl - Tablets
• Extra Strength Tylenol - Caplets, Cool Caplets, EZ Tablets and Rapid Release Gelcaps
• Motrin IB - Caplets and Tablets
• Regular Strength Tylenol - Caplets and Tablets
• Rolaids - Chewables
• Simply Sleep - Caplets
• St. Joseph Aspirin - Chewables and Tablets
• Tylenol 8 Hour - Caplets
• Tylenol Arthritis - Caplets and Geltabs
• Tylenol PM - Caplets, Geltabs and Rapid Release Gelcaps

Some consumers have reported an unusual moldy, musty, or mildew-like odor that, in a small number of cases, triggered episodes of nausea, stomach pain, vomiting, or diarrhea. The company believes that the odor is due to traces of the chemical 2,4,6-tribromoanisole (TBA). The health effects of TBA have not been extensively studied, but are believed not to be serious. TBA is generated when certain molds break down a fungicide that sometimes is applied to wood used to make shipping pallets.

McNeil first became aware of the problem in 2008, when it received more than 60 complaints of a musty odor in two lots of Tylenol Arthritis Relief Caplets, including at least 8 complaints of "gastrointestinal adverse events." In September 2008, the Company confirmed the presence of the odor, but did no testing to evaluate the possibility of a chemical contaminant or product deterioration. Nor did McNeil issue a field alert.

The Company received additional complaints in the spring and summer of 2009, but did not issue a field alert until September 18th, and did not initiate a product recall until December 4th, while undergoing an FDA inspection.

The FDA inspection report, posted earlier this week on the agency's website, reveals numerous problems at the Puerto Rico factory where the recalled products are manufactured. The main findings include:

1. An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.
2. Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
3. The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
4. There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
5. Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
6. Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
7. Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.

Please check your medicine cabinet for the products listed above, and follow this live link to the recall notice for a complete list of recalled products and lot numbers.

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