|
Recall of certain TYLENOL® Extra Strength Rapid Release Gels and BENADRYL® Allergy ULTRATAB™ Tablets products (6/15/2010)
Why is McNeil adding lots to the January recall?
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company’s January 15th, 2010 product recall. The additional lots involved are four product lots of Benadryl® Allergy UltraTab™ Tablets, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH Tylenol® Rapid Release Gels, 50 count sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW). This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.
Which product lots have been added to the recall?
A full list of the previously recalled products and lot numbers is available at www.mcneilproductrecall.com . The affected product lot number for each product can be found on the side of the bottle label.
The additional recalled products are:
Product Name |
Product Form |
Lot Number |
NDC Number |
UPC Code |
BENADRYL® ALLERGY ULTRATAB™ TABLETS 100 count |
Ultratab Tablet |
AJA008, ADA194,
ABA022, ABA264 |
50580-226-10
|
312547170338
|
EXTRA STRENGTH TYLENOL® Rapid Release Gels 50 count |
Rapid Release Gelcap |
ASA202 |
50580-488-50
|
300450488503
|
What was the reason for the January recall?
The January 15th, 2010 recall was initiated as a result of consumer complaints of a musty or moldy odor that has since been linked to 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 wooden pallets that transport and store product packaging materials. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote.
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.
Does this recent recall show that you continue to discover new TBA problems?
No. All of these products were produced before the January 15th, 2010 recall but were inadvertently omitted from the initial recall action.
Have there been any adverse events reported with the specific product lots just recalled?
We have very few reports of adverse effects associated with these products and those we have seen were temporary, non-serious events.
Is this recall related to the recent recall of infants’ and children’s medicines?
No, these are entirely separate issues.
What should consumers do if they have the product?
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 http://www.fda.gov/safety/medwatch/default.htm.
When will you have these products back on store shelves?
Product lots of Benadryl® Allergy UltraTab™ Tablets and EXTRA STRENGTH Tylenol® Rapid Release Gels not included in this recall continue to be available.
| 
