27 Apr Andolex-C Oral Gel (benzydamine HCL 10 mg/cetylpyridinium Cl 1 mg/g)
| Company name & Address | registration number | Batch number(s) |
Expiry date(s) |
Pack size | First distribution date |
Re-call Classification |
Recall date |
|
iNova Pharmaceuticals (Pty) Ltd 15E Riley Road, Bedfordview, 2007
|
33/16.4/0285
|
126355
127226
|
02/2025 04/2025
|
10 g tube |
Batch 126355: 08/04/2022 Batch 127226: 26/05/2022 |
Class III Type C
|
07.Oct.2022 |
Reason for recall
iNova Pharmaceuticals took the decision to initiate a voluntary recall on Andolex-C Oral Gel. The recall is instituted due to Stability data assessed at 3 and 6 months which showed an out of specification result on microbiological growth on both batches and the assay value of Cetylpyridinium Chloride which tested below approved limits for batch 127226.
Advice to HCPs/Distributors/Public:
The company requested immediate blockage of stock on hand of the batches mentioned above, and for the distributors to be in contact with their customers who purchased the affected stock.
Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.
Reporting side effects
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