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Medicine Quality Alert: Class II Medicines Recall of Budecort 100 Inhaler, Batch 5GB1889

Cipla Limited has initiated a voluntary recall of Budecort 100 Inhaler, Batch 5GB1889.

From: Pharmacy and Poisons Board

Published: 31st  March 2026

Recall Reference Number: REC/2026/001

Recall Classification: Class II

Recall Level: Retail/Facility Level

Manufacturer: Cipla limited

LTR: Imperial Managed Solutions East Africa Ltd

Product name: Budecort 100 Inhaler

Active Pharmaceutical Ingredient: Budesonide

Affected counties: All

Affected Batches

S/N

Batch No

Mfg Date

Exp Date

Pack Size

1.     

5GB1889

08/2025

07/2027

100mcg

Brief description of the problem

The voluntary recall has been initiated because the actuator used for the Budecort 100 Inhaler, Batch 5GB1889 is not compatible with the Bespak valve. The compatibility of an actuator with a Bespak valve is crucial for ensuring the reliable, precise, and consistent delivery of medication in the inhaler.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing, or use of Budecort 100 Inhaler, Batch 5GB1889 immediately, and contact Imperial Managed Solutions East Africa Ltd to arrange return.

Action for patients and caregivers

Patients are advised to talk to their healthcare professional if they have the above batch of Budecort 100 Inhaler, Batch 5GB1889.

Further Information

For any inquiries on consignments please contact Imperial Managed Solutions East Africa Ltd, by email at regulatorykenya@dpworld.com or via telephone at +254 71 905 8145 or +254 79 651 3837

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 Budecort 100 Inhaler, Batch 5GB1889
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