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Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, Rolaids Multi-Symptom plus Anti-Gas Softchews: Recall - Foreign Materials in Products
AUDIENCE: Consumer
ISSUE: McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. recalled all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas Softchews distributed in the United States, following consumer reports of foreign materials in the product, including metal and wood particles.
BACKGROUND: The company’s investigation determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the investigation is ongoing, production of these products has been suspended and will not restart until corrective actions have been implemented.
RECOMMENDATION: Consumers who purchased product included in this recall should contact McNeil Consumer Healthcare, either at http://www.rolaids.com
or by calling 1-888-222-6036 for instructions about receiving a refund. Consumers who have medical concerns or questions should contact their healthcare provider.
Consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the company Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420
