What is the reason for the recall?

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling 21 lots of over-the-counter medicines. The lots involved are sold in the U.S., Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago and Jamaica. This action is a follow-up to a product recall that McNeil Consumer Healthcare originally announced on Jan. 15, 2010, which was initiated following consumer complaints of a musty or moldy odor, which has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). The risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

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Which product lots are included in the recall?

The affected product lot number for each product can be found on the side of the bottle label.

FULL RECALLED PRODUCT LIST:

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What was the cause of the "musty, moldy" odor that resulted in the January 15th recall?

McNeil Consumer Healthcare determined that the reported uncharacteristic odor was caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the source of TBA was the result of a breakdown of a chemical that is applied to wood used to build wood pallets that transport and store product packaging materials. The risk of serious adverse medical events is remote.

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Have there been consumer complaints of a "musty moldy" odor, or symptoms reported in relation to the product lots involved in this recall?

To date, there have been no complaints of a musty or moldy odor associated with the lots involved in the recall. The risk of serious adverse medical events is remote. We have a few reports of non-serious, gastrointestinal-related adverse medical events such as stomach discomfort, associated with these lots. It is not known whether these adverse event reports are related to the presence of TBA.

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Why weren’t all these product lots recalled in the earlier recalls (January 15 or June 15)?

The January recall was a very large and complicated recall that involved more than 500 product lots. Continuing reviews identified the five lots that were recalled on June 15th, and recently determined that the packaging materials used in these 21 lots had been shipped and stored on the same type of wood pallet that was tied to the presence of TBA in earlier recalled lots. We have been working with our external suppliers to track down such shipments and tie them to specific lots of manufactured product.

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Is this recall related to the recent recall of infants' and children's medicines?

No. This recall is entirely separate.

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What should consumers do if they have the product?

While the risk of serious adverse medical events is remote, consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Requests for reimbursement can be made at www.mcneilproductrecall.com. Consumers who have medical concerns or questions should contact their healthcare provider.

Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/safety/medwatch/default.htm.

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What is 2,4,6 tribromoanisole, how is it used, and is it dangerous?

The chemical 2,4,6-tribromoanisole (TBA) can result from the breakdown of a chemical applied to wood used to build pallets that transport and store packaging materials. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate TBA and has shared that information with the FDA. This continued analysis confirms that the risk of serious adverse medical events is remote.

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When will you have these products back on store shelves?

Other lots of most of these products that are not impacted by the recall are available now in stores. Some of the lots included in this recall involve products that are no longer manufactured or distributed. You can access our product locator on our brand websites for more information.

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Will you be offering a refund for the product I purchased and has been recalled?

Yes. McNeil Consumer Healthcare is offering two options for consumers who have purchased products affected by this recall. You can receive either a refund for the average retail price of the product or a coupon for a free replacement product. Click here to request a refund or product coupon. To process your refund or coupon, you will need the NDC number and Lot number from the product that has been recalled. The NDC number can be found above the brand name on the label of the bottle. The Lot number can also be found on the label and is usually placed vertically on the label.

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