| TGA Action ID |
RC-2023-RN-00837-1 |
| Type of Product |
Medicine |
| Product Name/Description |
MIDAZOLAM 50mg/ 10mL solution for injection
Batch number: F3138F02
Expiry date: 12/24
ARTG 160208
(MIDAZOLAM VIATRIS 50 mg/ 10 mL midazolam solution for injection ampoule) |
| ARTG Number |
160208 |
| Action Type |
Product Defect Correction |
| Action Level |
Retail |
| Hazard Classification |
Class I |
| Reason for the Action |
A single ampoule of Urapidil Stragen 50mg/10ml has been detected in Midazolam Alphapharm 50 mg/10 mL Injection (Batch F3138F02).
Urapidil is not listed on the ARTG but is included in the Poisons Standard in Schedule 4.
The incorrect medicine may be administered if not detected by the health care professional prior to administration.
The likelihood of the wrong medicine injected to patients is very low due to routine checks at bedside prior to administration. |
| Instructions for Customers/Users |
Pharmacists are asked to:
-Examine their stock of Midazolam Alphapharm 50 mg/10 mL injection, batch F3138F02, for the presence of ampoules labelled as Urapildil Stragen 50mg/10mL.
-If the ampoule label states Urapildil Stragen 50 mg/10 mL immediately quarantine any defect stock.
-Return defect units to the wholesaler for a credit.
Wholesalers must:
- Check stock and return units of Batch F3138F02 to Alphapharm Pty Ltd for a credit if defective units are present.
-For any further information phone: 1800 274 276.
This action has been finalised on 8/8/2024. |
| Action Commencement Date |
25/09/2023 |
| Responsible Entity |
|
| Contact Information |
1800 274 276 - Alphapharm Pty Ltd (Viatris) |