27 Apr NEXIPRAZ IV (Esomeprazole 40mg)
|
Company name & Address: |
Registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
| Ranbaxy Pharmaceuticals (Pty) Ltd 14 Lautre Road, Stormill Extension 1 Roodepoort |
46/11.4.3/0606 |
HAE3136A |
May 2025 |
10’s |
31 May 2024 |
Class III Type C |
08 July 2024 |
Reason for recalls
The recall is initiated because an out of specification result observed in the TAMC test (Total Aerobic Microbial Count) for the in-process (pre-filtered bulk solution) sample.
Advice to HCPs/Distributors/Public
We request that you refrain from selling the affected batch of Nexipraz IV 40mg Vials, Batch HAE3136A. Please return all remaining stock to your supplying warehouse or distributor with immediate effect. Ranbaxy Pharmaceuticals (Pty) Ltd will collect all your stock which will be credited.
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.