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(HealthNewsDigest.com) – FORT WASHINGTON, Pa., Dec. 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, 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 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(R) Extra Strength Softchews, Wild Cherry
ROLAIDS(R) Extra Strength Softchews, Wild
Cherry, 6 count 9015A, 9016A, 312547655200
9019A, 9140A,
9138A, 9210A,
9211A, 9315A,
9316A
ROLAIDS(R) Extra Strength Softchews, Wild
Cherry, 18 count (3 packs of 6 count) 9075A, 9076A, 312547655255
9103A, 9098A,
9104A, 9239A,
9240A, 9348A
ROLAIDS(R) Extra Strength Softchews, Wild
Cherry, 42 count (7 packs of 6 count) 9065A, 9068A, 312547655316
————-
9069A, 9131A,
————-
9132A, 9208A,
————-
9209A, 9286A,
————-
9287A
—–
ROLAIDS(R) Extra Strength Softchews, Cherry
ROLAIDS(R) Extra Strength Softchews,
Cherry, 6 count 0109A, 0114A, 312547655200
0115A, 0134A,
0135A, 0165A,
0238B, 0239A,
0239C, 0262A,
0264A
ROLAIDS(R) Extra Strength Softchews, 9349AG2,
Cherry, 18 count bag 9350AG1, 300450649188
0015AG2,
0015AG3,
0050AG1,
0051AG1,
0053BG2,
0106BG2,
0107AG1,
0108AG1,
0108BG3,
0108CG1,
0129BG1,
0133AG1,
0133AG2,
0165BG2,
0191BG1,
0191CG1,
0191DG1,
0213AG2,
0238AG1,
0238AG2,
0246AG1
ROLAIDS(R) Extra Strength Softchews, 9350AG2,
Cherry, 36 count bag 0012AG1, 300450649362
——–
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
——-
ROLAIDS(R) Extra Strength plus Gas Softchews, Tropical
Fruit
ROLAIDS(R) Extra Strength plus Gas
Softchews, Tropical Fruit, 6 count 9005A, 9006A 312547065733
ROLAIDS(R) Extra Strength plus Gas
Softchews, Tropical Fruit, 12 count (2
packs of 6 count) 9022A, 9027A, 312547065757
9118A, 9119A,
9195A, 9196A
ROLAIDS(R) Extra Strength plus Gas
Softchews, Tropical Fruit, 36 count (6
packs of 6 count) 9166A, 9167A 312547065771
————
ROLAIDS(R) Multi-Symptom plus Anti-Gas Softchews,
Tropical Fruit
ROLAIDS(R) Multi-Symptom plus Anti-Gas
Softchews, Tropical Fruit, 6 count 0017B, 0095A, 300450657060
0096B, 0259A,
0260A
ROLAIDS(R) Multi-Symptom plus Anti-Gas 9351BG1,
Softchews, Tropical Fruit, 12 count bag 9352AG1, 300450657121
0016AG1,
0059AG2,
0059BG1,
0059BG2,
0060AG2,
0167AG2,
0167AG3,
0203AG1,
0204AG1
ROLAIDS(R) Multi-Symptom plus Anti-Gas 9352AG2,
Softchews, Tropical Fruit, 24 count bag 9352BG2, 300450657244
—————————————- ——– ————
0016AG2,
0017AG1,
———
0057BG1,
0058AG1,
———
0059AG1,
0059BG3,
———
0060AG1,
0129AG1,
———
0132AG1,
0167AG1,
———
0167BG1,
0204AG2,
———
0205AG1,
0230AG1,
———
0231AG1
——-
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