Somatuline Autogel 90mg & 120mg (Lanreotide acetate)

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.

Download latest version
Version: 1
Date Updated: 27/06/2025
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance