Rolaids Products Recalled - Foreign ‘Particles’ Found

HARTFORD — All Rolaids Extra Strength Softchews, Extra Strength plus Gas Softchews, and Multi-Symptom plus Anti-Gas Softchews are being voluntarily recalled by their manufacturer for possibly containing foreign materials, Department of Consumer Protection Commissioner Jerry Farrell said today. He encouraged consumers to discontinue use of these products immediately and contact the company for a refund.

McNeil Consumer Healthcare, a Division of McNEIL-PPC, Inc is voluntarily recalling all lots of the Rolaids Softchews distributed in the United States following some consumer reports of foreign materials in the product, including metal and wood particles. The company’s investigation determined that foreign materials were potentially introduced into the product during manufacturing at a third party manufacturer.

According to McNeil Consumer Healthcare, while the risk of serious adverse health consequences is remote, consumers who have these recalled products are advised to discontinue use, and anyone with medical concerns or questions about taking these products should contact their healthcare provider.

Production of these specific Softchews has been suspended until corrective actions have been implemented, the company reports.

Consumers who purchased the Softchews should contact McNeil Consumer Healthcare, either at http://www.rolaids.com or by calling 1-888-222-6036 (Monday to Friday, 8 am to 8 pm, and Saturday and Sunday, 9 am to 5 pm) for refund instructions.

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 US Food and Drug Administration.