| TGA Action ID |
RC-2023-RN-00699-1 |
| Type of Product |
Medicine |
| Product Name/Description |
SODIUM CHLORIDE INTRAVENOUS INFUSION BP 0.9% 100/50 mL
Article number: 3521330
Batch numbers: 21146403, 21305401, 21182401
ARTG 154967
(0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION BP 0.9% sodium chloride 50 mL intravenous infusion) |
| ARTG Number |
154967 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Due to a production related deviation from the specifications. Routine quality controls revealed a potential cross-contamination of the primary packaging containers of medicinal products for infusion. Batches of solutions for infusion produced after Midazolam solution for infusion were detected to be cross-contaminated with traces of Midazolam above the PDE (Permitted Daily Exposure).
A toxicological assessment has been done to evaluate the potential risk for patients and concluded that the highest detected levels of Midazolam are below the smallest therapeutic dose. Nevertheless, allergic reactions to Midazolam cannot be excluded. B. Braun has not received any reports of suspected adverse drug reactions for the affected batches which relate to the detected or potential cross-contamination with Midazolam. |
| Instructions for Customers/Users |
Quarantine and return affected articles. Alternatively destruction is allowable on site as long as a medical destruction certificate is provided.
All impacted products will be credited.
This action has been closed out on 27/11/2023 |
| Action Commencement Date |
1/08/2023 |
| Responsible Entity |
|
| Contact Information |
1800 251 705 - B Braun |