A Not So Soft-Chew

Wood and metal particles found in certain Rolaids Soft Chews

/ Author:  / Reviewed by: Joseph V. Madia, MD

Rolaids Extra-Strength Softchews, Extra-Strength plus Gas Softchews and Multi-Symptom plus Anti-Gas Softchews are being recalled after complaints of foreign particles being present in the product.

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.comor 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.htmRegular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. 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 here for examples or call the Consumer Care Center at 1-888-222-6036.

FULL RECALLED PRODUCT LIST:

ROLAIDS Extra Strength Softchews, Wild Cherry

ROLAIDS Extra Strength Softchews, Wild Cherry, 6 count

Lot Number: 9015A, 9016A, 9019A, 9140A, 9138A,9210A, 9211A,9315A, 9316A
UPC: 312547655200

ROLAIDS Extra Strength Softchews, Wild Cherry, 18 count (3 packs of 6 count)

Lot Number: 9075A, 9076A, 9103A, 9098A, 9104A, 9239A, 9240A, 9348A
UPC: 312547655255

ROLAIDS Extra Strength Softchews, Wild Cherry, 42 count (7 packs of 6 count)

Lot Number: 9065A, 9068A, 9069A, 9131A, 9132A, 9208A, 9209A, 9286A, 9287A
UPC: 312547655316

ROLAIDS Extra Strength Softchews, Cherry

ROLAIDS Extra Strength Softchews, Cherry, 6 count

Lot Number: 0109A, 0114A, 0115A, 0134A, 0135A, 0165A, 0238B, 0239A, 0239C, 0262A, 0264A
UPC: 312547655200

ROLAIDS Extra Strength Softchews, Cherry, 18 count bag

Lot Number: 9349AG2, 9350AG1, 0015AG2, 0015AG3, 0050AG1, 0051AG1, 0053BG2, 0106BG2, 0107AG1, 0108AG1, 0108BG3, 0108CG1, 0129BG1, 0133AG1, 0133AG2, 0165BG2, 0191BG1, 0191CG1, 0191DG1, 0213AG2, 0238AG1, 0238AG2, 0246AG1
UPC: 300450649188

ROLAIDS Extra Strength Softchews, Cherry, 36 count bag

Lot Number: 9350AG2, 0012AG1, 0013AG1, 0014AG1, 0015AG1, 0015AG4, 0050AG2, 0053AG2, 0053BG1, 0053BG2, 0094AG1, 0106AG1, 0106BG1, 0108AG2, 0108BG2, 0191AG1, 0139BG2, 0165BG1, 0191BG1, 0207AG1, 0207AG2, 0213AG1, 0227AG1, 0246AG2, 0247AG1, 0265AG1, 0266AG1
UPC: 300450649362


ROLAIDS Extra Strength plus Gas Softchews, Tropical Fruit

ROLAIDS Extra Strength plus Gas Softchews, Tropical Fruit, 6 count

Lot Number: 9005A, 9006A
UPC: 312547065733

ROLAIDS Extra Strength plus Gas Softchews, Tropical Fruit, 12 count (2 packs of 6 count)

Lot Number: 9022A, 9027A, 9118A, 9119A, 9195A, 9196A
UPC: 312547065757

ROLAIDS Extra Strength plus Gas Softchews, Tropical Fruit, 36 count (6 packs of 6 count)

Lot Number: 9166A, 9167A
UPC: 312547065771

ROLAIDS Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit

ROLAIDS Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 6 count

Lot Number: 0017B, 0095A, 0096B, 0259A, 0260A
UPC: 300450657060

ROLAIDS Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 12 count bag

Lot Number: 9351BG1, 9352AG1, 0016AG1, 0059AG2, 0059BG1, 0059BG2, 0060AG2, 0167AG2, 0167AG3, 0203AG1, 0204AG1
UPC: 300450657121

ROLAIDS Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 24 count bag

Lot Number: 9352AG2, 9352BG2, 0016AG2, 0017AG1, 0057BG1, 0058AG1, 0059AG1, 0059BG3, 0060AG1, 0129AG1, 0132AG1, 0167AG1, 0167BG1, 0204AG2, 0205AG1, 0230AG1, 0231AG1
UPC: 300450657244 

Reviewed by: 
Review Date: 
December 14, 2010