27 Apr Smecta Go (Diosmectite)
|
Company name & Address: |
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 |
51/11.10/1000 |
W12706 W18869 W19120 W19246 C51926 C57569 |
2025/05/31 2025/07/31 2025/07/31 2025/08/31 2027/01/31 2025/05/31 |
12 x 10g |
2022/08/26 2022/10/27 2023/04/05 2023/04/05 2024/07/17 2024/10/08 |
Class III Type C |
31 March 2025 |
Brief description of the problem (reason for recall)
This recall is initiated as a result of a typographical artwork error on the primary and secondary label. Potassium Sorbate 0.1% was incorrectly translated to Afrikaans as “natriumsorbaat 0.1%”. The PI/PIL remains unaffected.
Advice for health professionals and distributors
- 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 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.