Massive Recall of ROLAIDS announced

McNeil Consumer Healthcare is recalling 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.

• 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
  

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

Foreign materials

The action follows consumer reports of foreign materials in the product, including metal and wood particles. An investigation by the company has determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer.

McNeil says that while the risk of serious adverse health consequences is remote, consumers who have purchased these recalled products should stop using them.

Production of the recalled products has been halted and McNeil says it will not restart production until corrective actions have been implemented.

Consumer advice

Consumers who purchased product included in this recall should contact McNeil Consumer Healthcare, either at online 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 health care provider.

Any adverse reactions may also be reported to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program either online, by regular mail with this form or by fax at 1-800-FDA-0178.

The recall is being conducted with the knowledge of the FDA.