| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2023-RN-00965-1 |
| Product Name/Description |
ZACTIN TABS fluoxetine 20 mg (as hydrochloride) dispersible tablet
All Batches
ARTG 90913 |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
Alphapharm Pty Ltd has informed the TGA Recalls Section of recovery of N-Nitroso-Fluoxetine impurity present in all batches of ZACTIN TABS fluoxetine 20 mg (as hydrochloride) dispersible tablet. |
| Recall Action |
Recall |
| Recall Action Instructions |
Wholesalers are to return stock to Alphapharm Pty Ltd for a credit or refund. |
| Contact Information |
1800 274 276 - Alphapharm Pty Ltd |