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Medicine quality alert: Class II Recall of Dawaflox Powder for Oral Reconstitution (Flucloxacillin 125mg/5ml)

The Pharmacy and Poisons Board has issued a mandatory recall of batches of 2006121 & 2012085 of Dawaflox Powder for Oral Reconstitution (Flucloxacillin 125mg/5ml) manufactured by Dawa Limited due to Failed Assay Test (less amount of active ingredient)

From: Pharmacy and Poisons Board

Published: 24/06/2022

Recall Reference Number: REC/2022/03

Recall Classification: Class II

Recall Level: Retail/Facility Level

Company name: Dawa Limited

Product name: Dawaflox Powder for Oral Reconstitution (Flucloxacillin 125mg/5ml) Biodopa 250mg Tablets

Active Pharmaceutical Ingredient: Flucloxacillin

Affected batches:

Batch number

Expiry date

Pack size

2006121

2012085

11/2023

05/2023

100ml

100ml

Brief description of the problem

Two batches  2006121 and 2012085 of Dawaflox Powder for Oral Reconstitution (Flucloxacillin 125mg/5ml) Failed Assay Tests (less amount of the active ingredient)

Advice for healthcare professionals

You are advised to immediately quarantine the remaining stock of the impacted batches and stop supplying or dispensing the batches. You are advised to contact Dawa Ltd and arrange for the return of the product

Advice for patients

Dawaflox Powder for Oral Reconstitution (Flucloxacillin 125mg/5ml) is used for the management of bacterial infections. You are advised to your prescribing healthcare professional if you have the above batches of Dawaflox Powder for Oral Reconstitution (Flucloxacillin 125mg/5ml).

Further Information

For stock enquiries, please contact Dawa Limited by email to bhavisha.vora@dawalifesciences.com or by phone at +254 713 275 777

You are advised to promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:

For any further information please contact the Pharmacy and Poisons Board by email: pms@ppb.go.ke

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Medicine quality alert: Class II Recall of Dawaflox Powder for Oral Reconstitution (Flucloxacillin 125mg/5ml)