Product description
(TGA R2004/1226-9). Vioxx (Rofecoxib)tablets 12.5mg, (AUST R 69872). Vioxx (Rofecoxib) tablets 25mg (AUST R 69871). Vioxx (Rofecoxib) oral suspension 12.5mg/5mL (AUST R 69870). Vioxx (Rofecoxib) oral suspension 25mg/5mL (AUST R 69869). All batches.
See a list of details to help identify the product
Reason the product is recalled
The company has decided to recall Vioxx based on new information from a recent clinical study which showed that there was an increased risk of cardiovascular events such as heart attack and stroke beginning after 18 months of treatment.
The hazards to consumers
Increased risk of cardiovascular and cerebrovascular disease. (Heart Attack and Stroke).
What consumers should do
Consumers to call the Merck Sharp & Dohme Customer Service Line on 1800 066 426.
Details to help identify the product
Supplier running the recall
Merck Sharp & Dohme Pty Ltd
Where the product was sold
Nationally
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2004/7266 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.