27 Apr Lubri-A sterile lubricating sachets (Glycerine (B.P. or U.S.P) 9.9% m/m)
| Company name & Address: |
Registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
| EletroSpyres HealthCare
9 Friesland Drive, Westfield, Modderfontein, Johannesburg, 1609, South Africa |
00001323MD |
M204;M205;M085; M108; M156; M109 |
M204(2026-05-30); M205(2026-06-22); M085(2026-01-03) M108(2026-01-03); M156(2026-01-26) |
2,5 g sachet |
Oct.2022 |
Class I Type A |
18.Dec.2023 |
Reason for recall
The recall was initiated because of numerous complaints received by SAHPRA due to a countrywide outbreak across the country regarding patients who developed a rare fungal pathogen, Wickerhamomyces anomalus (previously Candida pelliculosa), following the use of Lubri-A use. Following a collaborative outbreak investigation, the source was found to have contaminated several batches of the product, Lubri-A-Sterile Lubricating 2.5 g Jelly sachets.
Advice to HCPs/Distributors/Public:
The company requested their clients countrywide to stop using the affected product batches and return all units on hand of the affected batches to their supplying wholesaler or distributor immediately for a full replacement product.
- EletroSpyres HealthCare also urged their clients to reach out to the company’s dedicated product recall hotline at: 011-608-3998 or on What’s App: 082-355-8862 or email them at sales@electrospyres.com.
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.