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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:

For any further enquiries contact the post-marketing surveillance unit at the Pharmacy and Poisons Board via email at pms@ppb.go.ke

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Medicines Quality alert: Class II Recall of Alka-UR Effervescent Granules Batch Number 3620100