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