Bemetrazole 400mg Tablets (Metronidazole)

Bemetrazole 400mg Tablets (Metronidazole)

Company name & Address:  

registration number

 

Batch number(s)

 

Expiry date

 

Pack size

 

First date of release

 

Re-call Classification

 

Recall date

 

Ranbaxy Pharmaceuticals (Pty) Ltd

14 Lautre Road, Stormill Extension 1. Roodepoort, Johannesburg 1724, South Africa

 

X/20.2.6/84

 

AC80212 and AC80213

 

08/2024 (both batches)

 

500’s

 

 

26.Sep.2022 (both batches)

 

Class II Type B

 

 

18.Aug.2023

 

Reason for recall

This recall was initiated due to discolouration of tablets.

 

Advice to HCPs/Distributors/Public:

The company requested their clients to refrain from selling any of the affected batches of Bemetrazole 400mg, Batch AC80212 and AC80213, and to return all remaining stock to their 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.

Download latest version
Version: 1
Date Updated: 18/08/2024
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance