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:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
- Mobile application: mPvERS both Android and iOS
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)