27 Apr Flucloxacillin 250 Capsules (Flucloxacillin 250 Oethmaan)
| Company name & Address: | registration number | Batch (Bulk) number(s) | Expiry date | Pack size | First distributed | Re-call Classification | Recall date |
| Oethmaan Biosims (Pty) Ltd 07A Sherwood House
Greenacres Office Park Corner of Victory and Rustenburg Roads Victory Park Johannesburg. Gauteng 2195 South Africa |
44/20.1.2/0816 |
MP25071
MP25072 MP25073 MP25151 MP25152 MP25224 MP25225 MP25257 |
12/2026
12/2025 01/2027 02/2027 02/2027 02/2027 02/2027 03/2027 |
40’s
40’s 20’s 40’s 40’s 40’s 40’s 20’s |
14/05/2025
02/06/2025 03/04/2025 23/06/2025 17/07/2025 23/07/2025 14/08/2025 15/08/2025
|
Class II Type C |
18. December.2025 |
Brief description of the problem (reason for recall)
The recall is initiated because Oethmaan Biosims (Pty) Ltd. was informed by the manufacturer of the out of specification results for assay during stability testing of Flucloxacillin 250 Oethmaan capsules. Oethmaan Biosims (Pty) Ltd. has therefore taken the decision to initiate a voluntary recall on all batches packed into blisters thereafter by the manufacturer.
Advise for health professionals and distributors:
Oethmaan Biosims (Pty) Ltd request that you refrain from selling any of the affected batches of Flucloxacillin 250 Oethmaan and return them to your supplying warehouse or distributor with immediate effect. Oethmaan Biosims (Pty) Ltd will replace affected stock.
For further product information, please call Oethmaan Biosims Pty (Ltd) on 011 433 0602.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated. A rapid alert was also shared with PIC’s member countries.
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.