Medicines Quality Alert: Class II Recall of Normnil (Albendazole 400mg) Batch Number 2103104, 2012082, 2007067, 2007098, 2006202, 2006200
The Pharmacy and Poisons Board has initiated a mandatory recall of Normnil (Albendazole 400mg) batches; 2103104, 2012082, 2007067, 2007098, 2006202, 2006200 manufactured by Dawa Life Sciences.
From: Pharmacy and Poisons Board
Published: 11th April 2023
Recall Reference Number: REC/2023/006
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Dawa Life Sciences, Kenya
Product name: Normnil
Active Pharmaceutical Ingredient: Albendazole 400mg
Affected counties: All
Affected Batches
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
2103104 | 03/2021 | 12/2020 | 500’s |
2012082 | 12/2020 | 11/2023 | 500’s |
2007067 | 07/2020 | 06/2020 | 500’s |
2007098 | 07/2020 | 06/2023 | 100’s |
2006202 | 06/2020 | 05/2023 | 500’s |
2006200 | 06/2020 | 05/2023 | 500’s |
Brief description of the problem
The Pharmacy and Poisons Board has mandated Dawa Life Sciences to initiate an urgent recall of Normnil (Albendazole 400mg) batches; 2103104, 2012082, 2007067, 2007098, 2006202, and 2006200. The product is being recalled following several market complaints on molding, cracking, and change in color. Quality control analysis confirmed discrepancies were observed in the coloration of the tablets, deviating from registered specifications.
Action for healthcare professionals
You are advised to immediately quarantine and stop supplying the remaining stock of impacted batches of the product. Dawa Life Sciences will contact healthcare professionals directly to arrange the return of the products.
Action for patients and carers
Patients who have been prescribed the impacted batches of Normnil (Albendazole 400mg) should seek advice from their healthcare providers. This is because you require a review with your prescribing healthcare professional to discuss alternative treatment options.
Further Information
For stock inquiries please contact Dawa Life Sciences by email at: info@dawalifesciences.com, sales@dawalifesciences.com, or via telephone at +254 733 764 747/20 356 9904
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 post-marketing surveillance unit at the Pharmacy and Poisons Board by email: pms@ppb.go.ke
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Medicines Quality Alert: Class II Recall of Normnil (Albendazole 400mg) Batch Number 2103104, 2012082, 2007067, 2007098, 2006202, 2006200