27 Apr Zyklot 75, tablets (clopidogrel)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Re-call Date |
| Zydus Healthcare SA (Pty) Ltd, Southdowns Office Park, 22 Karee Street, Centurion, 0157, Pretoria
South Africa. |
A46/8.2/0972 |
M912323 AND M000240 |
31/07/2021(M912323) and 30/11/2021(M000240) |
30 |
12/11/2020 |
Class II Type B |
20 May 2021 |
Reason for recall
Austell Pharmaceuticals took the decision to initiate a voluntary recall on Azithromycin 200 mg/5 ml Powder for suspension. The recall is to be instituted due to some of the containers having defective primary packaging resulting in the seal being discoloured, which is not in line with the product specifications.
Advice to HCPs/Distributors/Public:
The company requested immediate return of all units on hand of the batches mentioned above to their supplying wholesaler or distributor for a full credit.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all distribution points, recall 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.
Reason for recall
Austell Pharmaceuticals took the decision to initiate a voluntary recall on Azithromycin 200 mg/5 ml Powder for suspension. The recall is to be instituted due to some of the containers having defective primary packaging resulting in the seal being discoloured, which is not in line with the product specifications.
Advice to HCPs/Distributors/Public:
The company requested immediate return of all units on hand of the batches mentioned above to their supplying wholesaler or distributor for a full credit.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all distribution points, recall 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.