The Pharmacy and Poisons Board (PPB) has issued an urgent recall of Flamodip (Amlodipine) 5 mg tablets, batch no. FLD303, manufactured by Medico Remedies PVT Limited. This recall, announced on Friday, was prompted by a critical labeling error that misrepresented the drug's contents.

In a statement, the PPB explained, "The secondary packaging is labeled as Flamodip-5 (Amlodipine), while the primary packaging is labeled as Flamidopril-5 (Enalapril)," creating a dangerous mismatch between the external and internal labels.

The board has directed all pharmaceutical outlets, hospitals, and healthcare professionals to immediately stop sales and distribution of the affected batch. Members of the public have also been urged to return any products from this batch to their nearest healthcare facilities or suppliers and refrain from using the medication.

About the Drug

Flamodip (Amlodipine) is commonly used to treat high blood pressure by relaxing blood vessels, allowing blood to flow more easily and reducing the heart's workload. However, incorrect use or overdose of such medication can lead to severe side effects, particularly affecting the cardiovascular system. In some cases, it may cause life-threatening conditions like pulmonary edema, where fluid accumulates in the lungs, obstructing breathing and potentially leading to death.

Reporting Adverse Reactions

The PPB has encouraged the public to report any cases of substandard medication or adverse drug reactions. Reports can be made via phone at 0795743049, using USSD code *271#, or online through the link https://pv.pharmacyboardkenya.org/users/mpublic. Additionally, the mobile app mPvERS or email addresses pv@ppb.go.ke and pms@ppb.go.ke can be used to report issues.

Healthcare providers are urged to remain vigilant and inform their patients about the recall to prevent any harm.