27 Apr Clonam 0.5 mg and Clonam 2 mg film coated Tablets (clonazepam)
|
Company name & Address: |
registration number |
Batch number |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
|
Ascendis Health Ltd 31 Georgian Crescent East Bryanston, South Africa |
0.5 mg: 45/2.5/0820 |
7862006-8 (3 batches) |
July-2022 |
84’s (Carton with Blister) |
12.July.2019 |
Class II Type B |
20 September 2021 |
|
2 mg: 45/2.5/0821 |
7872005-6 (2 batches) |
June-2022, July- 2022 |
84’s (Carton with Blister) |
12.July.2020 |
Class II Type B |
20 September 2021 |
*CLONAM 0.5mg and CLONAM 2 mg are both on state tender, code: RT289-2019, tender numbers: 51401516-00002 & 51401516-00001.
Reason for recall
The products are being recalled due to quality defect: the tablet description should be cross-scored, but instead the tablet has only a single score.
Advice to HCPs/Distributors/Public:
All remaining stock at distributor put in quarantine to avoid sale and to prevent further stock from being distributed. Customers/ health professionals were sent a recall letter and feedback was requested regarding quantity of stock on hand. Available stock at customers to be returned and placed in quarantine.
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.