Medicine Quality Alert: Class I Medicine Recall of Flamodip (Amlodipine) 5 Mg Tablets Batch No FLD303
The Pharmacy and Poisons Board has mandated Harleys Limited to initiate an urgent recall of Flamodip (Amlodipine) 5 Mg Tablets Batch No FLD303 Manufactured By Medico Remedies Pvt Ltd.
From: Pharmacy and Poisons Board
Published: 26th September 2024
Recall Reference Number: REC/2024/025
Recall Classification: Class I
Recall Level: Consumer-level
Local Technical Representative: Harleys Limited
Manufacturer: Medico Remedies Pvt Ltd, India
Product name: Flamodip
Active Pharmaceutical Ingredient: Amlodipine 5mg
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
FLD303 | 10/2023 | 09/2026 | 30 Tablets |
Brief description of the problem
The product is being recalled due to wrong product (label and contents are different products). The label of the secondary package for Flamodip (Amlodipine) 5 Mg Tablets reads Flamodip-5 (Amlodipine) whereas the primary package reads Flaminopril-5 (Enalapril).
Action for healthcare professionals
Quarantine all the remaining stock and stop further distribution, sale, issuing, or use of the batch IMMEDIATELY. Await contact from Harleys Limited to arrange the return.
Action for patients and members of the public
Patients and members of the public who are in possession of the product batch are advised to IMMEDIATELY return the product to the nearest healthcare facility.
Further Information
For inquiries about consignments of the impacted batch, please contact Harleys Limited at: regulatory@harleysltd.com, info@harleysltd.com or Phone: +254 20 4261000, Mobile: +254 722 202030 | 0773 106 788 | 0737 203030.
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
- USSD code at *271#
- Mobile application: mPvERS both Android & iOS
- 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 “the Board” via email at pms@ppb.go.ke and Recall Feedback Form
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Medicine Quality Alert: Class I Medicine Recall of Flamodip (Amlodipine) 5 Mg Tablets Batch No FLD303