| TGA Action ID |
RC-2025-RN-00935-1 |
| Type of Product |
Medicine |
| Product Name/Description |
BLACK & GOLD IBUPROFEN 200 mg sugar coated tablet blister pack
Batches: 2410078A & 2501018A
Expiry: Sep-2027 & Dec-2027 |
| ARTG Number |
165316 |
| Action Type |
Recall |
| Action Level |
Wholesale |
| Hazard Classification |
Class II |
| Reason for the Action |
Nova Pharmaceuticals identified a typographical error in the Directions for Use on product cartons released after 2 July 2024. The maximum recommended daily dose is incorrectly stated as a maximum of 8 tablets (1,600mg) per 24 hours instead of 6 tablets (1,200mg). This error may result in consumers taking a higher than approved dose of ibuprofen, increasing the risk of dose-related adverse effects.
There have been no adverse event reports associated with this product reported to Nova for the past three years. |
| Instructions for Customers/Users |
Wholesalers are to:
· Inspect all stock immediately and quarantine affected stock of 2410078A & 2501018A
· Complete the attached Customer Response form and return it to devanshi.p@novapharm.com.au
· Return affected stock on hand with the completed response form
This action has been closed out on 13/02/2026 |
| Action Commencement Date |
5/11/2025 |
| Responsible Entity |
|
| Contact Information |
02 8090 7855 - Nova Pharmaceuticals |