Important Information – Voluntary Nationwide Recall
Novo-Gesic Forte® 500 mg (Acetaminophen) Tablets (DIN 00482323)
Labelling Error - Two (2) Lots (35364729A and 35217483A)
Distributed by Teva Canada Limited | Canadian Market Only
Toronto, Canada (October 6, 2021) - Teva Canada Limited, with the knowledge of Health Canada, is initiating a nationwide voluntary Type I retail level recall of two (2) lots of over-the-counter Novo-Gesic Forte® 500 mg (Acetaminophen) Tablets due to a labelling error where the maximum daily dose indicated in tablets on the label is incorrect. This recall does not affect any other lots or dosage strengths of Novo-Gesic® or Novo-Gesic Forte® Tablets distributed by Teva Canada Limited.
The correct maximum daily dosage should read 4,000 mg or 8 tablets (8 tablets x 500 mg). However, the label error indicates a higher number of tablets for the maximum daily dose and reads, 4,000 mg or 12 tablets. Taking more than the maximum daily dose of Acetaminophen may cause severe or possibly fatal liver damage. Symptoms of liver damage may include: yellow skin or eyes, dark urine, sweating, nausea, vomiting, stomach pain, unusual tiredness, loss of appetite. As a result of the labelling error and due to the risks associated with exceeding the recommended maximum daily dose of Acetaminophen, Teva Canada Limited, out of an abundance of caution, is voluntarily recalling both lot numbers as listed below.
To date, Teva Canada Limited has not received any reports of adverse events related to the lots being recalled.
Products Subject to the Voluntary Recall
The affected products and lot numbers are:
|First Date of Sale
|Novo-Gesic Forte® (Acetaminophen) Tablets
|Bottle, 100 Tablets
|Novo-Gesic Forte® (Acetaminophen) Tablets
|Bottle, 1000 Tablets
This recall does not affect any other lots or dosage strengths of Novo-Gesic® or Novo-Gesic Forte® Tablets distributed by Teva Canada Limited.
What to Do
Check the lot numbers (listed above) on the bottle label: Consumers who have purchased Novo-Gesic Forte® 500 mg are asked to check the lot numbers (listed above) on the front panel of the label on the bottle it is packaged in. If it has either of the listed lot numbers, they are advised to stop using the product and return it to the pharmacy/store where they purchased it.
Novo-Gesic Forte® Caplet (Acetaminophen) is an over-the-counter (OTC) product and is used for the treatment of mild to moderate pain and the reduction of fever in adults and children 12 years and older. It has been marketed by Teva Canada Limited since December 1982 and is available in 3 packaging configurations: Bottles of 100, 1000 and Unit Dose (100’s). The Unit Dose (100’s) packaging configuration is not impacted by the subject recall.
Teva Canada Limited is notifying its distributors, retailers, and health care professionals to arrange for the return / credit of any returned recalled product lot. Distributors and retailers that have inventory of the recalled product have been advised to immediately stop distribution and isolate remaining quantities in their control and return the recalled product lots to Teva Canada Limited.
Medical Questions or Side Effects
This Public Communication is not intended as medical advice. To understand the implications of this information to your health, it is important that you consult a doctor or health care professional.
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of unexpected side effects in patients using Novo-Gesic Forte® 500 mg (Acetaminophen) Tablets should be reported to Teva Canada Limited and/or Health Canada.
Teva Canada Limited:
Medical Affairs & Drug Information
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario M1B 2K9
1-800-268-4127, Option 3
You can report any suspected adverse reactions associated with the use of health products to Health Canada:
- Call Toll-Free: 1-866-234-2345
- Online: healthcanada.gc.ca/medeffect
- Fax Toll-Free: 1-866-678-6789
Canada Vigilance Program
Marketed Health Products Directorate
Health Canada, Postal Locator 0701E
Ottawa, Ontario K1A 0K9
About Teva Canada Limited
For over 50 years, Teva Canada Limited has been part of the fabric of Canadian families by providing affordable healthcare solutions in the form of over-the-counter and prescription products. This trust and legacy is built on Teva Canada Limited’s patient focus and on the assurance it will deliver products of the highest quality. The company takes recalls of this nature very seriously and has commenced a full review of the established processes that led to the labelling error. Corrective actions will be implemented to prevent any future labelling errors.
This recall is being conducted with the full knowledge of Health Canada.