News

McNeil Consumer Healthcare Announces Voluntary Recall of All Lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength Plus Gas Softchews, and ROLAIDS® Multi-Symptom Plus Anti-Gas Softchews Sold in the United States

Fort Washington, PA (December 9, 2010) -- McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, andROLAIDS® 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, andROLAIDS® 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 www.rolaids.com or 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: www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: 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).

The lot numbers for the recalled products can be found on the back or the bottom of thepackage.

CONSUMER INQUIRIES:
1-888-222-6036 (Mon-Fri 8 a.m. to 8 p.m. EST, and Sat-Sun 9 a.m. to 5 p.m. EST)

FULL RECALLED PRODUCT LIST:

Product Name    Lot Number     UPC
ROLAIDS® Extra Strength Softchews, Wild Cherry
ROLAIDS® Extra Strength Softchews, Wild Cherry, 6 count 9015A, 9016A, 9019A, 9140A, 9138A, 9210A, 9211A, 9315A, 9316A   312547655200

ROLAIDS® Extra Strength Softchews, Wild Cherry, 18 count (3 packs of 6 count)   9075A, 9076A, 9103A, 9098A, 9104A, 9239A, 9240A, 9348A    312547655255

ROLAIDS® Extra Strength Softchews, Wild Cherry, 42 count (7 packs of 6 count)   9065A, 9068A, 9069A,9131A, 9132A, 9208A, 9209A, 9286A, 9287A   312547655316

ROLAIDS® Extra Strength Softchews, Cherry
ROLAIDS® Extra Strength Softchews, Cherry, 6 count      0109A, 0114A, 0115A, 0134A, 0135A, 0165A, 0238B, 0239A, 0239C, 0262A, 0264A   312547655200

ROLAIDS® Extra Strength Softchews, Cherry, 18 count bag 9349AG2, 9350AG1, 0015AG2, 0015AG3, 0050AG1, 0051AG1, 0053BG2, 0106BG2, 0107AG1, 0108AG1, 0108BG3, 0108CG1, 0129BG1, 0133AG1,0133AG2, 0165BG2, 0191BG1, 0191CG1, 0191DG1, 0213AG2, 0238AG1, 0238AG2, 0246AG1 300450649188

ROLAIDS® Extra Strength Softchews, Cherry, 36 count bag 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 300450649362

ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit, 6 count     9005A, 9006A 312547065733

ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit, 12 count (2 packs of 6 count)       9022A, 9027A, 9118A, 9119A, 9195A, 9196A    312547065757

ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit, 36 count (6 packs of 6 count)       9166A, 9167A    312547065771

ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 6 count 0017B, 0095A, 0096B, 0259A, 0260A   300450657060

ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 12 count bag    9351BG1, 9352AG1, 0016AG1, 0059AG2, 0059BG1, 0059BG2, 0060AG2, 0167AG2, 0167AG3, 0203AG1, 0204AG1 300450657121

ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 24 count bag    9352AG2, 9352BG2,0016AG2, 0017AG1, 0057BG1, 0058AG1, 0059AG1, 0059BG3, 0060AG1, 0129AG1, 0132AG1, 0167AG1, 0167BG1, 0204AG2, 0205AG1, 0230AG1, 0231AG1 300450657244

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McNeil Consumer Healthcare Announces Voluntary Recall of All Lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength Plus Gas Softchews, and ROLAIDS® Multi-Symptom Plus Anti-Gas Softchews Sold in the United States

Online: www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178

Employees