27 Apr Sereflo 25/125 HFA
| Company name & Address: | registration number | Batch (Bulk) number(s) | Expiry date | Pack size | First distributed | Re-call Classification | Recall date |
|
Cipla Medpro (Pty) Ltd Building 2 Junxion Park 10 Elephant Lane Century City South Africa 7441 |
42/21.5.4/0219 |
5IB0093 |
November 2026 |
1 unit |
07 March 2025
|
Class III Type C |
30.Jan.2026 |
Brief description of the problem (reason for recall)
This recall is initiated due to an out of specification result in the Aerodynamic Assessment of Fine Particles test [by Andersen Cascade Impactor test (APSD)] for Fluticasone Propionate during stability testing.
Advise for health professionals and distributors:
We request that you refrain from selling or dispensing any pack of the affected batch of Sereflo 25/125 HFA and return them to your supplying warehouse or distributor with immediate effect.
Cipla Medpro (Pty) Ltd. will collect all your stock which will be credited / replaced.
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.