| TGA Action ID |
RC-2025-RN-00003-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Progesterone injection USP, 500mg/10 mL (50mg/mL) [Multiple Dose Vial]
Batch: 1PR24010
Expiry: 02/2027
Supplied via SAS |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class I |
| Reason for the Action |
Link Pharmaceuticals has received a complaint about glass particle contamination in a vial of Progesterone Injection USP, 500 mg/10 mL (50 mg/mL), Batch No.: 1PR24010, Expiry: 02/2027. This product is used to treat amenorrhea and abnormal uterine bleeding caused by hormonal imbalance. The issue poses a risk to patient safety and product sterility. |
| Instructions for Customers/Users |
1. Inspect your stock and quarantine units from the affected batch (1PR24010) to prevent further use.
2. Fax or email the completed acknowledgement form to customerservice@linkgroup.com.au or call 02 8401 9788.
3. Contact Link Medical Products to arrange collection of the affected stock for destruction and the provision of replacement units.
4. Notify relevant staff members of this recall.
5. If the product has been supplied or transferred to another organisation location, forward this letter to the relevant party.
6. Keep this letter in a prominent position for one month. |
| Action Commencement Date |
6/01/2025 |
| Responsible Entity |
|
| Contact Information |
02 8401 9777 - Link Pharmaceuticals |