Categorized | Business, Health, Recalls

McNeil recalls Tylenol caplets due to musty or moldy odor

MEDIA RELEASE

March 29, 2011- Fort Washington, PA – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling one product lot of TYLENOL® 8 Hour Extended Release Caplets 150 count bottles distributed in the United States. McNeil is taking this action as part of our ongoing surveillance and monitoring efforts that identified a small number of complaints of a musty or moldy odor. The uncharacteristic odor is thought to be caused by the presence of trace amounts of chemicals called 2,4,6-tribromoanisole (TBA) and 2,4,6-trichloroanisole (TCA). This voluntary action is being taken as a precaution and the risk of adverse medical events is remote. The product was manufactured at the McNeil Consumer Healthcare plant in Fort Washington, PA prior to the company’s voluntary closure of the facility in April 2010.

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

FULL RECALLED PRODUCT LIST:

Product Name                       Lot Number    UPC Code
TYLENOL® 8 HOUR EXTENDED RELEASE   ADM074        300450297181
CAPLET 150 count

Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.

Any adverse reactions may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.ht…
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms…. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
Separately, McNeil Consumer Healthcare is also adding ten lots of other products to a wholesale level recall it initiated on January 14th, 2011. That recall did not require any action by consumers or healthcare providers and was not undertaken on the basis of adverse events. More information about this wholesale level recall is available at www.mcneilproductrecall.com.

These recalls are being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Click here to see Frequently Asked Questions on the recall of one lot of TYLENOL® 8 Hour (Lot # ADM074)

Click here to request a refund or product coupon for TYLENOL® 8 Hour lot # ADM074

Click here to see Frequently Asked Questions on the recall of certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, TYLENOL® Sinus, BENADRYL® and SUDAFED PE® products

Click here for a list of product lots from the Wholesale Recalls from January 14, 2011 and March 29, 2011

Click here to see Information About Other Recalls

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