| TGA Action ID |
RC-2025-RN-00405-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Clarithromycin Eberth 500 mg powder for solution
Batch/Lot/Serial Number: GLC01N03/A
Expiry Date: 03/2027
Supplied via SAS pathway |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Some deficiencies in the GMP area were discovered during an inspection at the contract manufacturer. This recall is conducted as a precautionary measure since an impact on sterility cannot be ruled out.
To date, there are no reports of sterility problem causing harm. |
| Instructions for Customers/Users |
Customers are to:
- Please quarantine all affected stock and contact Orspec Pharma to reconcile this process.
- No alternative stock is available currently. Contact Orspec Pharma at regulatory@orspecpharma.com for assistance.
This action has been closed out on 10/06/2025 |
| Action Commencement Date |
24/04/2025 |
| Responsible Entity |
|
| Contact Information |
regulatory@orspecpharma.com - Orspec Pharma |