27 Apr Zodoray 0.25 μg capsules (Alfacalcidol).
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First date of release |
Re-call Classification |
Recall date
|
| Strides Pharma SA (Pty) Ltd.
Address: 106 16th Road, Building 2, Midrand, 1686, South Africa. |
53/22.1.4/0679 |
BN 7250117 |
Dec. 2023 |
30’s
|
19.Jul.2022 |
Class II Type C
|
30.Jan.2023 |
Reason for recall
This recall is initiated due to an out of specification result for the assay test at 3 months testing interval at long term storage conditions i.e., 25°C/ 60%RH.
Advice to HCPs/Distributors/Public:
The company requested their clients to quarantine and refrain from selling any of the affected batch of Zodoray 0,25 µg capsules and return them to their supplying warehouse or distributor with immediate effect for reimbursement.
Proposed action taken and its urgency: A SAHPRA approved recall letter distributed to all distribution points and 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.