| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2022-RN-01100-1 |
| Product Name/Description |
XYLOCAINE 2% with ADRENALINE 1:200000 Multi Dose VIAL (with Preservative) pack of 10x20ml
Batch: 9949864
Not included on ARTG (supplied via s19A) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/08/2022 |
| Responsible Entity |
|
| Reason/Issue |
Pro Pharmaceuticals Group have inadvertently supplied product containing preservative. Pro Pharmaceuticals have received s19A authorisation to supply the product without preservative.
The packaging of the two products clearly states with preservative and without preservative. There is no known defect with the actual supplied product. If the product was supplied in its original box, clinicians would be aware that the product contains preservatives.
No adverse events have been reported to date due to the error. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised by Pro Pharmaceutical to locate the impacted batch and dispose the stock immediately.
Customers are also advised by Pro Pharmaceuticals to monitor their symptoms for any allergic reaction or adverse effects who have been received the drug with preservatives as per hospital's protocol.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
0432996644 - Sandip - Pro Pharmaceuticals |