PPB - Services

Complaints, Feedback and Enquiry

Medicine Quality Alert: Class III Medicine Recall of Bisotrol (Bisoprolol 5mg) Tablets, Batch Number JJI023002

Sai Pharmaceuticals Limited, Kenya, has initiated an urgent voluntary recall of Bisotrol (Bisoprolol 5mg) Tablets BN JJI023002

From: Pharmacy and Poisons Board

Date of Recall Initiation: 3rd January 2025

Recall Reference Number: REC/2025/001

Recall Classification: Class III

Recall Level: Wholesale Level

Local Technical Representative: Sai Pharmaceuticals Limited, Kenya.

Manufacturer: Ipca Laboratories Ltd, India

Product name: Bisotrol

Active Pharmaceutical Ingredient: Bisoprolol 5mg

Affected Counties: All

Affected Batch

Batch Number

Date of Manufacture

Date of expiry

Pack Size

JJI023002

02/2023

01/2026

100’s

Brief description of the problem

The product is being recalled following out-of-specification (OOS) results observed in the Related Substances test of Bisotrol – 5 Tablet at 12M on 30C/75% stability conditions.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batches immediately. Await contact from Sai Pharmaceuticals Limited to arrange the return.

Action for patients and caregivers

No further action is required by patients as this is a Wholesaler/Distributor level recall

Further Information

For inquiries about consignments of the impacted batches, please contact Sai Pharmaceuticals Limited at info@saipharm.com or sales@saipharm.com. or via telephone: tel:+254-20-4454301/2/3, tel:+254-733-741-911, tel:+254-721-243-322

Promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:

For any further information please contact the post-marketing surveillance unit at the Pharmacy and Poisons Board by email: pms@ppb.go.ke

Download document

Medicine Quality Alert: Class III Medicine Recall of Bisotrol (Bisoprolol 5mg) Tablets, Batch Number JJI023002