18 Aug Frusemide 20 mg/2 ml Fresenius (Furosemide)
| Company name & Address: | Registration number | Batch number(s) | Registered Expiry Date (Labelled Expiry Date) | Pack size | First release date | Re-call Classification | Recall date |
| Fresenius Kabi South Africa (Pty) Ltd
7 Kingfisher Avenue Midpoint 162 Tonetti Street Halfway House Ext. 7, Midrand Gauteng, 1685 PO Box 4156 Halfway House Gauteng, 1685 |
K/18.1/207 |
90TEA870
90TIA300 90TKB190 90TLA480 90UCA000 90UEA840 90UIA510 90UIA530 90WEA230 |
30 April 2027 (30 April 2029) 31 August 2027 (31 August 2029) 30 September 2027 (30 September 2029) 31 October 2027 (31 October 2029) 28 February 2028 (28 February 2030) 30 April 2028 (30 April 2030) 31 August 2028 (31 August 2030) 31 August 2028 (31 August 2030) 30 April 2029 (30 April 2031) |
10 units per carton |
30 June 2024 16 October 2024 03 December 2024 28 January 2025 31 March 2025 29 July 2025 30 October 2025 27 November 2025 27 May 2026 |
Class III Type B |
31 July 2026 |
Brief description of the problem (reason for recall)
This recall is initiated due to the stated batches of Frusemide 20 mg/2 ml Fresenius labelled with an incorrect expiry date. Although these batches do not comply with the requirements of Act 101 of 1965 in terms of the requirements of printed packaging material labelling, all the batches are still well within their correct shelf-life at this point in time, and therefore unlikely to cause any adverse health reaction.
Advice for health professionals and distributors:
Fresenius Kabi South Africa (Pty) Ltd requests that you return the affected batches of Frusemide 20 mg/2 ml Fresenius to your supplying warehouse or distributor, along with the relevant invoice, with immediate effect.
Fresenius Kabi South Africa (Pty) Ltd will credit all returned stock.
We thank you in advance for your co-operation and apologise for any inconvenience caused.
If you should have any questions or require further details regarding this matter, please do not hesitate to contact us as per the details below:
Tel: +27 (0) 41 403 1640
Tel: +27 (0) 11 545 0000
Mob: +27 (0) 82 606 4786
Email: safety.fksa@fresenius-kabi.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.