Kenya’s Pharmacy and Poisons Board (PPB) has announced a recall of Flamodip tablets manufactured by Medico Remedies due to a critical labeling error.
This recall is essential for ensuring patient safety, particularly those using this medication to manage high blood pressure and related conditions.
Details of the Recall
- Reason for Recall: The PPB noted that the product’s labeling does not accurately reflect its contents.
- Specifically, while the secondary packaging is labeled as Flamodip-5 (Amlodipine), the primary packaging mistakenly indicates it as Flamodip-5 (Enalapril). This discrepancy poses a serious risk, as it may lead to patients receiving incorrect medication.
- Warning Issued: The PPB has warned the public against using, selling, and distributing the affected product batch. Uses of Flamodip and Enalapril
- Flamodip-5 (Amlodipine): Typically used to treat high blood pressure in adults and children aged six years and older. It can be prescribed alone or in combination with other medications. Additionally, it effectively manages certain types of angina (chest pain) and coronary artery disease, which involves the narrowing of blood vessels supplying blood to the heart.
- Enalapril: This medication treats high blood pressure and heart failure, characterized by weakened heart function. While both drugs lower blood pressure, they have different mechanisms of action. Amlodipine, a calcium channel blocker, relaxes blood vessels for easier blood flow. In contrast, Enalapril, an angiotensin-converting enzyme (ACE) inhibitor, relaxes and widens blood vessels, helping the heart pump blood more effectively. Implications for Patients
Patients currently taking Flamodip 5mg tablets are advised to:
- Cease Use Immediately: Discontinue the recalled product and consult a healthcare provider for appropriate alternatives.
- Return the Product: Follow local guidelines to return the affected batch to pharmacies or healthcare facilities. Reporting and Further Actions
The PPB boss urged members of the public to report any suspected cases of sub-standard medicines or adverse drug reactions to the board through its official website, email, mobile number, mPvERs mobile application, and USSD code.
The recall of Flamodip 5mg tablets due to a labeling error underscores the importance of medication safety and accuracy.
Patients are urged to take this recall seriously and consult healthcare providers for guidance. Contacting a healthcare professional or the PPB is highly recommended for any further inquiries or concerns.
