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McNeil Consumer Healthcare (Canada) Urgently Recalls Various Rolaid Products Sold in Canada
- Starting date:
- December 10, 2010
- Posting date:
- December 10, 2010
- Type of communication:
- Information Update
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Product Safety, Contamination
- Audience:
- General Public
- Identification number:
- RA-110004023
Health Canada is informing Canadians that McNeil Consumer Healthcare (Canada) is voluntarily recalling all lots of Rolaids® Ultra Strength SoftChews® and Rolaids® Ultra Strength SoftChews® plus Gas Relief from the Canadian market. McNeil is requesting that wholesalers, pharmacies and other retail locations immediately stop sale of this product.
The company has informed Health Canada that they are taking this action following consumer reports of foreign materials in the product, including metal and wood particles. The company is advising consumers who have purchased these recalled products to discontinue use.
Health Canada reminds Canadians who have concerns about these products to consult with their health care practitioner or contact McNeil Consumer Healthcare by calling the Johnson & Johnson Inc. Consumer Contact Centre at 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 more information, please visit the company's website ([NJS_FILE:d46d09f4-f707-4c9c-8956-83b8d6c6be7b:f35c304b-a4e3-4af0-99fb-78da25d798b9] - 119 Kb).
Health Canada will continue to monitor the safety of health products on the Canadian market, including those manufactured at McNeil Consumer Healthcare plants and will inform Canadians if new safety information arises. Health Canada will take appropriate action to help protect the health and safety of Canadians should further risks to health be identified.
Product Recall Information
All lot numbers and all flavours of Rolaids® SoftChews® are affected by this recall.
| Description | DIN |
|---|---|
| Rolaids® Ultra Strength SoftChews® Plus Gas Relief Tropical Fruit 36's | DIN 02269171 |
| Rolaids® Ultra Strength SoftChews® Plus Gas Relief Tropical Fruit 24's | DIN 02269171 |
| Rolaids® Ultra Strength SoftChews® Cherry 6's | NPN 02247315 |
| Rolaids® Ultra Strength SoftChews® Vanilla 6's | NPN 02247315 |
| Rolaids® Ultra Strength SoftChews® Cherry 42's | NPN 02247315 |
| Rolaids® Ultra Strength SoftChews® Cherry 36's | NPN 02247315 |
| Rolaids® Ultra Strength SoftChews® Vanilla 42's | NPN 02247315 |
| Rolaids® Ultra Strength SoftChews® Vanilla 36's | NPN 02247315 |
To report a suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send it to us using one of these methods:
- Fax: 1-866-678-6789
- Internet: www.healthcanada.gc.ca/medeffect
-
Mail:
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9
Media enquiries
Health Canada
613-957-2983
Public enquiries
613-957-2991
1-866-225-0709