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Medicine Quality Alert: Class II Medicines Recall of Hepacel 25000 (Heparin Sodium 25000 IU/ML) Injection Batch No. SL26A001E

Pro-Med Pharmaceuticals Ltd has initiated a voluntary recall of Hepacel 25000 (Heparin Sodium 25000 IU/ML) Injection Batch No. SL26A001E.

From: Pharmacy and Poisons Board

Published: 20th July 2026

Recall Reference Number: REC/2026/14

Recall Classification: Class II

Recall Level: Retail/Facility Level

MAH/LTR: Pro-Med Pharmaceuticals Ltd

Manufacturer: Sanjar Pharma LLP, India

Product name: Hepacel 25000

Active Pharmaceutical Ingredient: Heparin Sodium 25000 IU/ML

Affected counties: All

Affected Batch

S/N

Batch No

Mfg Date

Exp Date

Pack Size

1.     

SL26A001E

01/26

12/28

Vial

Brief description of the problem

The voluntary recall was initiated following the receipt of complaints reporting clot formation during use of a dialysis machine.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing, or use of Hepacel 25000 (Heparin Sodium 25000 IU/ML) Injection Batch No. SL26A001E immediately and contact Pro-Med Pharmaceuticals Ltd to arrange return.

Action for patients and caregivers

Patients who have been administered the above batch of Hepacel 25000 are advised to consult their healthcare professional for further advice and appropriate clinical assessment.

Further Information

For any inquiries on consignments please contact Pro-Med Pharmaceuticals Ltd, by email at regulatory@promedpharma.co.ke or via telephone at 0722203700

Promptly report any case/s of suspected substandard and falsified products 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 and feedback on the product recall, contact the post-marketing surveillance unit at the Pharmacy and Poisons Board via email at pms@ppb.go.ke

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Medicine Quality Alert: Class II Medicines Recall of Hepacel 25000 (Heparin Sodium 25000 IU/ML) Injection Batch No. SL26A001E
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