| TGA Action ID |
RC-2020-RN-00252-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Sotalol Carinopharm 40 mg / 4 ml solution for injection
Batch Number: 015333
Expiry Date: 01/2022
Supplied under Special Access Scheme (SAS) |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Medsurge have received a report from a hospital pharmacy indicating that ampoules of the drug Orfiril 100 mg/ml solution for injection from the company Desitin Arzneimittel GmbH were found in a pack of Sotalol-Carinopharm 40 mg/4 ml solution for injection (5 ampoule size), supplied by Carinopharm GmbH.
The intermixing carries the risk of incorrect treatment of patients suffering from acute cardiac arrhythmias with an unindicated antiepileptic and associated undesirable, possibly life-threatening, pharmaceutical effects in patients. |
| Instructions for Customers/Users |
Customers are advised to inspect stock immediately and quarantine affected stock of Sotalol Carinopharm 40 mg / 4 ml solution for injection, Batch: 015333 Expiry 01/2022 on hand to prevent further use.
Medsurge will contact all impacted customers to organise return of affected goods.
This action has been closed out on 02/11/2020 |
| Action Commencement Date |
13/03/2020 |
| Responsible Entity |
|
| Contact Information |
1300 788 261 - Medsurge Healthcare Customer Service |