| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2015-RN-00092-1 |
| Product Name/Description |
AKINETON, biperiden hydrochloride
Batch Numbers: 327028D, 236698D and 255238D
AUST R 12792 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Link Healthcare is advising customers that due to a potential for the medicine to degrade sooner than expected batches 327028D, 236698D and 255238D of AKINETON, biperiden hydrochloride, 2mg tablets, AUST R 12792, are being recalled from the market. A stability lot of Akineton tablets tested for related substances at 12 months showed an out of trend (OOT) result for individual degradation product (single unknown impurity). The manufacturer is still investigating the issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Link Medical is requesting all the customers and consumers to quarantine and return the stock. Consumers can return the medicine to their pharmacy who can arrange stock recovery on their behalf.
This action has been closed-out on 28/02/2018. |
| Contact Information |
1800 181 060 - Link Healthcare Customer Service |