Medicines Quality alert: Class II Recall of Alka-UR Effervescent Granules Batch Number 3620100
National Pharmaceutical Industries Co is recalling Alka-Ur Batch Number 3620100 from the Kenyan market
From: Pharmacy and Poisons Board
Published: 21/02/2022
Recall Reference Number: REC/2022/02
Recall Classification: Class II
Recall Level: Retail/Facility Level
Manufacturer: National Pharmaceutical Industries Co (SAOG) Muscat, Sultanate of Oman
Product name: Alka-Ur Effervescent Granules
Active Pharmaceutical Ingredient: Sodium Bicarbonate 1.76 gm, Tartaric Acid 0.890 gm, Citric acid anhydrous 0.720 gm, Trisodium citrate anhydrous 0.630 gm. Also contains Saccharin Sodium
Brief description of the problem
The sachets are bloated and the powder is agglomerated.
Action for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier.
Action for patients and caregivers
The patients should continue taking other batches of the product other than the impacted batches and as prescribed by the healthcare professional.
Further Information
Promptly report any case/s of suspected substandard and falsified product or adverse reactions or insufficient control of symptoms to the nearest healthcare facility or the Pharmacy and Poisons Board through the following channels:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email: pv@ppb.go.ke and pms@ppb.go.ke
- Telephone number. 0795743049
- Mobile application: mPvERS both Android and iOS
For any further enquiries contact the post-marketing surveillance unit at the Pharmacy and Poisons Board via email at pms@ppb.go.ke
Download document
Medicines Quality alert: Class II Recall of Alka-UR Effervescent Granules Batch Number 3620100