| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2014-RN-01244-1 |
| Product Name/Description |
DBL (TM) Mitoxantrone Hydrochloride Injection Concentrate 20mg/10mL injection vial
Product Code: M4636A
Batch number: A024636AA
Expiry Date: Jul 2015
AUST R Number: 82469 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
An Out-of-specification (OOS) result was obtained for an unknown impurity during the long term stability testing. Batch No. A024636AA of Mitoxantrone has failed specification for unknown impurity. An out of specification result may cause a delay of therapy or administration of a potentially sub-potent product; although the likelihood of harm due to this non-conformance is considered low.
A medical assessment was performed and indicated that this is not a patient safety risk and that the characterised unknown impurity is similar to the Mitoxantrone Active Pharmaceutical Ingredient and determined that the toxicity profile of the impurity would be similar. The results obtained for the unknown impurity remain within the maximum daily dose for Mitoxantrone. |
| Recall Action |
Recall |
| Recall Action Instructions |
Hospital pharmacists and wholesalers are asked to check their inventory and immediately quarantine any product from the affected batch number and return to the place of purchase. Hospira is expecting new batches of Mitoxantrone to be released by the end of January 2015. Alternate brands are available on the Pharmaceutical Benefits Scheme (PBS). This action has been closed-out on 03/08/2016. |
| Contact Information |
1300 046 774 - Hospira Customer Service |