The Pharmacy and Poisons Board (PPB) has issued a mandatory recall for a batch of Flomodip (Amlodipine) 5mg tablets, batch number FLD303, manufactured by Medico Remedies Pvt Ltd.
The Pharmacy and Poisons Board has advised all chemists healthcare facilities, professionals, and the general public to immediately halt the distribution, sale, and use of the specified batch.
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The recall is triggered by a labeling error that misidentifies the drug's content, posing potential health risks to users.
According to the PPB, the secondary packaging of the affected batch is labeled as Flomodip-5 (Amlodipine), while the primary packaging incorrectly labels the tablets as Flaminopril-5 (Enalapril).
Though both Amlodipine and Enalapril are used to manage high blood pressure and cardiovascular conditions, they belong to different drug classes, work differently in the body, and have unique side effects and indications.
This labeling discrepancy can lead to confusion and unintended administration of the incorrect medication, potentially endangering patients who are expecting a specific drug treatment.
Immediate Actions for Pharmacies, Healthcare Facilities, and Public
In response to the recall, the PPB has advised all pharmaceutical outlets, healthcare facilities, professionals, and the general public to immediately halt the distribution, sale, and use of the specified batch.
All stakeholders have been urged to return the product to the nearest healthcare facility or their respective suppliers for proper handling.
The PPB also encouraged the public to report any cases of suspected sub-standard medications or adverse drug reactions through various communication channels.
Amlodipine (Flomodip-5) is primarily used to treat high blood pressure (hypertension) and certain types of chest pain (angina).
It belongs to a class of medications known as calcium channel blockers, which relax the blood vessels, improve blood flow, and reduce the heart's workload, thus lowering blood pressure and preventing chest pain.
Enalapril (incorrectly labeled as Flaminopril-5) is also used to treat high blood pressure, heart failure, and to prevent complications after a heart attack.
It is part of the angiotensin-converting enzyme (ACE) inhibitors class, which helps relax blood vessels, making it easier for the heart to pump blood.