27 Apr Adco Midazolam Injection 5mg/5ml (Midazolam)
|
Company name & Address: |
Registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
Date Published |
| Adcock Ingram Critical Care Pty Ltd
1 Sabax Road, Aeroton, Johannesburg |
A40/2.2/0753 |
S3330 |
Sep 2026 |
Strip of 10 amps per carton |
Oct 2024 |
Class II Type C |
4 December 2024 |
09 December 2024 |
Brief description of the problem (reason for recall)
The recall is initiated because some units of the batch presented with low fill volumes, and therefore does not meet the final product specifications with respect to the volume.
Advice for health professionals and distributors
We request that you refrain from using or dispensing the affected batch of ADCO MIDAZOLAM INJECTION 5MG/5ML. All affected units from the batch must be isolated and quarantined.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.