27 Apr ZINERYT LOTION (Erythromycin 40 mg/ml and Zinc acetate 12 mg/ml)
|
Company name & Address: |
Registration number |
Batch number(s) |
Expiry date |
Pack size |
First date of release |
Re-call Classification |
Recall date |
| Adcock Ingram Limited
1 New Road, Midrand, 1685 |
34/13.12/0474 |
66869 |
September 2024 |
30ml |
16 August 2022 (initial batch) 11 March 2024 (rework batch) |
Class II Type B |
04 July 2024 |
Reason for recalls
The recall is initiated because there has been peroxide detected in the solvent component of the product and therefore the reconstituted solution is highly likely not to fulfil the specifications during its recommended shelf-life.
Advice to HCPs/Distributors/Public
We request that you refrain from selling the affected batch of ZINERYT LOTION and return the batch to your supplying warehouse or distributor with immediate effect. ADCOCK INGRAM LIMITED will collect all stock for full credit.
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.