27 Apr FLOMIST NASAL SPRAY (Fluticasone Propionate 50 mcg/ spray)
| Company name & Address | registration number | Batch number | Expiry date | Pack size | First distributed |
Re-call Classification |
Recall date |
|
Cipla Medpro (Pty) Ltd, Parc du Cap Building 9, Mispel Street, Bellville, 7530, South Africa |
37/21.5.1/0289 |
IC20685 |
Nov.2024 |
1 x 120 MD |
28 Sept.2022 |
Class II Type B
|
12.Dec. 2022 |
Reason for recall
The recall is due to an out of specification (OOS) result that was observed in Flomist nasal spray, batch no. IC20685. OOS result was observed in microbial enumeration test. The organism was identified as Burkholderia Cepacia
Cipla Medpro (Pty) Ltd, in South Africa took the decision to initiate a voluntary recall on batch IC20685.
Advice to HCPs/Distributors/Public:
The company requested their clients to refrain from selling or dispensing FLOMIST NASAL SPRAY, Batch No. IC20685 and to return all remaining stock to their supplying warehouse or distributor with immediate effect
Proposed action taken and its urgency: A SAHPRA approved recall letter distributed to all distribution points and recall 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.