Rolaids Extra Strength Plus Gas Relief Softchews FDA Alerts
The FDA Alerts below may be specifically about Rolaids Extra Strength Plus Gas Relief Softchews or relate to a group or class of drugs which include Rolaids Extra Strength Plus Gas Relief Softchews.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Rolaids Extra Strength Plus Gas Relief Softchews
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:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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
[12/09/2010 - Press Release - McNeil Consumer Healthcare]