Medicine Quality Alert: Class II Medicine Recall of Tricohist Expectorant Batch No 0723040
The Pharmacy and Poisons Board has mandated Biodeal Laboratories Ltd, Kenya, to initiate an urgent recall of Tricohist Expectorant Batch No 0723040
From: Pharmacy and Poisons Board
Published: 22nd October 2024
Recall Reference Number: REC/2024/027
Recall Classification: Class II
Recall Level: Retail/Facility Level
Manufacturer: Biodeal Laboratories Ltd, Kenya
Product name: Tricohist Expectorant
Active Pharmaceutical Ingredient: Diphenhydramine HCl B.P 5mg Promethazine HCl B.P 2.5mg Ephedrine HCl B.P 7.5mg Ammonium Chloride B.P 90mg Sodium Citrate B.P 45mg per 5ml
Affected Counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
0723040 | 07/2023 | 06/2026 | 60ml |
Brief description of the problem
The Pharmacy and Poisons Board conducted quality control testing of Tricohist Expectorant, to check for compliance with registered specifications. The product failed to comply with the specifications of the test parameter on Assay for Diphenhydramine HCL and Promethazine HCl.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing, or use of the above batches immediately. Await contact from Biodeal Laboratories Ltd to arrange the return.
Action for patients and caregivers
No further action is required by patients as this is a retail/hospital pharmacy and wholesaler-level recall.
Further Information
For inquiries about consignments of the impacted batch, please contact Biodeal Laboratories Ltd at: qa@biodealkenya.com or chriskibathi@biodealkenya.com or Tel: +254 720 333 829 or +254 734 333 829.
You are advised to promptly report any case(s) 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
- Mobile application: mPvERS both Android and iOS
- USSD code at *271#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
For any further enquiries and feedback on the product recall, kindly contact the post-marketing surveillance unit of The Pharmacy and Poisons Board Kenya via email at pms@ppb.go.ke
Download document
Medicine Quality Alert: Class II Medicine Recall of Tricohist Expectorant Batch No 0723040