Medicine Quality Alert: Class II Medicine Recall of Caryl Cough Expectorant
The Pharmacy and Poisons Board has mandated Biodeal Laboratories Ltd, Kenya, to initiate an urgent recall of Caryl Cough Expectorant Batch No 1022035.
From: Pharmacy and Poisons Board
Published: 6th June 2024
Recall Reference Number: REC/2024/013
Recall Classification: Class II
Recall Level: Retail/Facility Level
Manufacturer: Biodeal Laboratories Ltd, Kenya
Product name: Caryl Expectorant
Active Pharmaceutical Ingredient: Salbutamol Sulphate B.P. Bromohexine HCl B.P. & Guaiphenesin B.P.
Affected Counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
1022035 | 10/2022 | 09/2025 | 100ml |
Brief description of the problem
The Pharmacy and Poisons Board conducted quality control testing of Caryl Cough Expectorant, to check for compliance with registered specifications. The product failed to comply with the specifications of the test parameter on Assay for Salbutamol, Bromhexine HCL, and Guaifenesin.
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
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Medicine Quality Alert: Class II Medicine Recall of Caryl Cough Expectorant