Health Canada is advising consumers that certain bottles of Robaxacet Caplets 40s do not have a child-resistant cap, despite the outer package indicating the bottle has a ‘child-lok’ cap. This poses a risk that children could accidentally ingest the product.
Accidental ingestion can result in acetaminophen overdose and serious health consequences, including liver damage. Each caplet contains 325 mg of acetaminophen. Early signs of overdose include nausea, vomiting, lethargy and sweating. Liver damage may result in liver failure or death. Abdominal pain may be the first sign of liver damage and may not be apparent for 24 to 48 hours.
Robaxacet Caplets 40s is advertised as a treatment for relief of back pain and muscle spasm, and is manufactured by Wyeth Consumer Healthcare Inc. The Drug Identification Number (DIN) for this product is DIN 02026805 and can be found on the product label.
Wyeth Consumer Healthcare Inc. informed Health Canada of the packaging problem and that it is recalling the affected product from the retail level. Wyeth Consumer Healthcare Inc. will be making changes to the product so that a child-resistant cap is present on the bottles.
This product, as with all medications, should be kept out of the reach of children. Parents and care-givers should not leave the product unattended believing that the product has a child-resistant cap.
The following table provides details related to the lot numbers involved and the expiry dates which are located on the product label:
| Lot Number | Expiry Date |
|---|---|
| 395384 | 09/2008 |
| 406180 | 01/2009 |
| 412787 | 04/2009 |
Consumers who would like to return the product may contact Wyeth Consumer Healthcare Inc. for a full refund of products with the above noted lot numbers. The company can be reached directly at 1-877-334-6360 for service in English or at 1-877-334-6367 for service in French.
Consumers requiring more information about this advisory can contact Health Canada’s public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To date, no adverse reactions associated with the lack of child-resistant caps have been reported to Health Canada. To report a suspected adverse reaction with this or any other health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:
Telephone: 866-234-2345
Facsimile: 866-678-6789
CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney’s Pasture, AL 0701C
Ottawa, Ontario K1A 0K9
Email: cadrmp@hc-sc.gc.ca
