Medicine Quality Alert: Class II Recall of Enril 5 (Enalapril Maleate USP 5mg) Batch Number KN532
The Pharmacy and Poisons Board has issued a mandatory recall of Enril 5 (Enalapril Maleate USP 5mg), Batch No KN532; due to out-of-specification results.
From: Pharmacy and Poisons Board
Published: 15/11/2023
Recall Reference Number: REC/2023/16
Recall Classification: Class II
Recall Level: Retail/Facility level
Local Technical Representative: Galaxy Pharmaceutical Limited
Manufacturer: Prism Life Sciences Ltd, India
Product name: Enril 5 Tablets
Active Pharmaceutical Ingredient: Enalapril Maleate USP 5mg
Affected Counties: All
Affected batches
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
KN532 | 02/2023 | 01/2026 | 30’s |
Brief description of the problem
Following routine market surveillance activities, the Pharmacy and Poisons Board (PPB) detected out-of-specification (OOS) results for Enril 5 (Enalapril Maleate usp 5mg), Batch no KN532.
Action for healthcare professionals
You are advised to stop supplying the above batches and immediately quarantine all remaining stocks. The company, Galaxy Pharmaceutical Limited, will contact healthcare professionals directly to arrange the return of the products.
Action for patients and carers
Patients currently prescribed Enril 5 (Enalapril Maleate usp 5mg), Batch no KN532 should be contacted by their prescribing healthcare professional. The patients should continue taking other batches of the product other than the impacted batches and as prescribed by the healthcare professional.
Further Information
For stock inquiries, please contact Galaxy Pharmaceutical Limited at: info@galaxypharma.co.ke or pvigilance@galaxypharma.co.ke or Tel: +254 3748551/2/3/4
You are advised to 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 Pharmacy and Poisons Board by email: pms@ppb.go.ke
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Medicine quality alert: Class II Recall of Enril 5 (Enalapril Maleate USP 5mg) Batch Number KN532