27 Apr Somatuline Autogel 90mg & 120mg (Lanreotide acetate)
| Company name & Address: | Product | Registration number | Batch number(s) | Expiry date | Pack size | First distributed | Re-call Classification | Recall date |
| Acino Pharma (Pty) Ltd
No 106, 16th Road, Midrand, 1686, Gauteng, South Africa |
Somatuline Autogel 90mg |
45/21.12/1023
|
003361 005988 009540 |
30 Nov 2026 31 Dec 2026 31 March 2027 |
1 pre-filled syringe |
10 March 2024 09 April 2024 12-06-2024 |
Class II Type C |
27.June.2025 |
| Somatuline Autogel 120mg | 45/21.12/1024 |
002243 002956 006373 |
30 Nov 2026 31 Dec 2026 28 Feb 2027 |
1 pre-filled syringe |
04 April 2024 22 April 2024 10 March 2024 |
Class II Type C | 27.June.2025 |
Brief description of the problem (reason for recall)
The recall has been initiated due to a quality defect that may cause the needle to detach from the syringe body.
Advice for health professionals and distributors
You are requested to take the following action with regards to the affected batches:
- Return the affected product to your supplying distributor/wholesaler for a credit.
- If any of the recalled stock could have been transferred from your hospital/healthcare facility to another, please inform them of this recall alternatively inform Acino and provide us with their details.
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.