27 Apr CELESTONE SOLUSPAN Suspension for injection (Betamethasone acetate/ Betamethasone sodium phosphate suspension)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
| Organon South Africa (Pty) Ltd
Spaces, 1st Floor 22 Magwa Crescent, Gateway West Waterfall City, Midrand, 2090 South Africa |
G2963 (Act 101/1965) |
W002691
U040010 W007137 NB: more batches found in the recall notification. |
Batch W002691: 03.2023 Batch U040010: 04.2023 Batch W007137: 05.2023 |
1ml, 2ml & 5ml |
29.Mar.2022
22.Feb.2022
21.Jun.2022 |
Class III Type C |
01.Feb.2023 |
Reason for recall
The recall is initiated because of the company’s use of a potentially corroded component in the manufacturing of the products at Heist. The use of the potentially corroded component creates the potential for stainless steel particulates in the formulations.
Advice to HCPs/Distributors/Public:
The company requested their clients to refrain from selling any of the affected batch(s) of CELESTONE SOLUSPAN Suspension for injection and to return them to their supplying warehouse or distributor with immediate effect. DSV Healthcare (Pty) Ltd will collect all their stock, which will be credited.
Proposed action taken and its urgency: A SAHPRA approved recall letter distributed to all distribution points and recall initiated
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.