27 Apr Emistop 4 mg (Ondansetron 4 mg)
|
Company name & Address: |
Registration number |
Batch number(s) |
Expiry date |
Pack size |
First distribution |
Re-call Classification |
Recall date |
| Pharma Dynamics (Pty) Ltd, 1st Floor, Grapevine House, Steenberg Office Park, Silwerwood Close, Westlake, Cape Town, 7945 |
45/5.10/0386 |
B5G0138A |
April 2026 |
Five ampoules packed in an outer carton |
18 August 2023 |
Class II Type B |
June 2024 |
Reason for recalls
Elevated levels of an unknown impurity was detected in the affected product and the ampoule appearance deviates from the Professional Information indicating a clear and colourless solution.
Advice to HCPs/Distributors/Public
Healthcare Professionals are urged to return all inventory of the affected EMISTOP 4 mg batch to their relevant distributor and/or wholesaler as soon as possible for reimbursement.
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.