| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00187-1 |
| Product Name/Description |
Chlorhexidine 0.5% in Alcohol 70%
Batch numbers: B04001 and B04003
ARTG number: 177526 |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
A precipitate was located in the Chlorhexidine 0.5% in Alcohol 70% solution. Testing of other bottles in the same batch found the precipitate present in all bottles tested. In addition a colour variation in darkness of the pink solution was observed between these tested bottles. This colour variation corresponded with the amount and size of the particulate matter in the solution (ie darker colour solution particles were less and smaller, and in lighter colour solutions the particles were larger).
This recall action was carried out prior to approval of the recall strategy by the TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Advanced Pharmaceuticals has recalled affected batches from distributors and hospitals. |
| Contact Information |
08 9638 5954 - Petrus Pharmaceuticals |