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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.

Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, Rolaids Multi-Symptom plus Anti-Gas Softchews: Recall — Foreign Materials in Products

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: www.fda.gov/MedWatch/report.htm

Read the MedWatch safety alert, including a link to the company Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm236907.htm