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Recall of ROLAIDS® Extra Strength Softchews



Company Contact:
Consumer Care Center
1-888-222-6036



November 15, 2010 - In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has initiated a voluntary recall of one product lot of ROLAIDS® Extra Strength Softchews, Cherry Flavor, 36 count package distributed in the United States.

This is a wholesale and retail level recall. No action is required by consumers or healthcare providers and consumers can continue to use the product. The recall was initiated as a precaution following consumer complaints of an uncharacteristic consistency or texture, traced to crystallized sugar in the product.

The affected product was manufactured by a third party for McNeil Consumer Healthcare, and the LOT number is 0053AG2, which can be found on the back of the ROLAIDS® Extra Strength Softchews, Cherry Flavor, 36 count package.

Consumers with questions should call our Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time.)
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***Additional information:

McNeil Consumer Healthcare Announces Voluntary Recall Of All Lots Of Rolaids® Extra Strength Softchews, Roldaids® Extra Strength Plus Gas Softchews, And Roldaids® Multi-Symptom Plus Anti-Gas Softchews Sold In The United States

Contact:
McNeil Consumer Healthcare
http://www.rolaids.com9
1-888-222-6036

FOR IMMEDIATE RELEASE - December 9, 2010 - McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews (full product details below) distributed in the United States. McNeil is taking this action following some consumer reports of foreign materials in the product, including metal and wood particles. The company's investigation has determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advises consumers who have purchased these recalled products to discontinue use.

While our investigation is ongoing we have suspended production of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews and will not restart production until corrective actions have been implemented.

Consumers who purchased product included in this recall should contact McNeil Consumer Healthcare, either at http://www.rolaids.com10
or by calling 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) for instructions about receiving a refund. 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: http://www.fda.gov/MedWatch/report.htm11
* Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm12. Mail to address on the pre-addressed form.
* Fax: 1-800-FDA-0178



This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Product Information: Product NDC numbers can be located on the label of the package above the brand name. Lot Numbers and Expiration Dates can be found on back, side or bottom label of the package. If you cannot find the NDC number, lot number, or expiration date on the label, Click here13 for examples or call the Consumer Care Center at 1-888-222-6036.

CLICK HERE14 TO FIND OUT IF YOUR ROLAIDS® SOFTCHEWS PRODUCT IS PART OF THE DECEMBER 9, 2010 RECALL.