Silver Spring, Maryland–(ENEWSPF)–December 13, 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 http://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: http://www.fda.gov/MedWatch/report.htm
- Regular 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.
CLICK HERE TO FIND OUT IF YOUR ROLAIDS SOFTCHEWS PRODUCT IS PART OF THE DECEMBER 9, 2010 RECALL.
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 |
||
|
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 |
CLICK HERE TO FIND OUT IF YOUR ROLAIDS SOFTCHEWS PRODUCT IS PART OF THE DECEMBER 9, 2010 RECALL.
CLICK HERE FOR A REFUND OF YOUR PRODUCT
CLICK HERE TO SEE FREQUENTLY ASKED QUESTIONS
CLICK HERE FOR INFORMATION ABOUT RECALLS OF ROLAIDS AND OTHER PRODUCTS
Source: fda.gov
