KENYA — The Pharmacy and Poisons Board (PPB) has issued a recall for a batch of Flamodip 5mg (Amlodipine) tablets, commonly prescribed for treating high blood pressure and cardiovascular conditions.
This recall, affecting Batch No. FLD303, comes shortly after a similar voluntary recall of S-Prazo (Esomeprazole Magnesium Delayed-Release Capsules 40mg), a drug used to manage heartburn and stomach ulcers.
In their statement, PPB said that this recent move to recall Flamodip tablets was as a result of a labeling issue identified during routine checks.
Dr. Fred Siyoi, the PPB’s Chief Executive Officer, clarified in the board’s latest statement that the recall was initiated due to a discrepancy between the primary and secondary packaging labels.
While the secondary packaging was labeled correctly as Flamodip-5 (Amlodipine), the primary packaging mistakenly carried the label Flaminopril-5 (Enalapril), leading to confusion regarding the medication’s contents.
As a result of this labeling error, Dr. Siyoi has directed all pharmaceutical outlets, healthcare providers, and other stakeholders to immediately cease the sale, distribution, and use of the affected batch.
He emphasized the need for urgent action, urging the public and medical professionals to stop further distribution and return any remaining stock of the recalled medication to the nearest healthcare facility or supplier.
“The Board advises all pharmaceutical outlets, healthcare facilities, healthcare professionals, and members of the public to stop further distribution, sale, issuing, or use of the product batch and return it to their nearest healthcare facility or respective suppliers,” said Dr. Siyoi.
He also called on the public to report any suspected cases of sub-standard medications or adverse drug reactions through the PPB’s official channels, including their website, email, mobile number, mPvERs mobile application, and USSD code *271#.
Flamodip, which contains Amlodipine, belongs to the class of calcium channel blockers and is primarily used to treat hypertension and chronic stable angina.
It works by inhibiting the influx of calcium into cardiac and vascular smooth muscle cells, promoting vasodilation, which helps lower blood pressure and reduce the heart’s oxygen demand.
Typically prescribed for patients with high blood pressure, coronary artery disease, or angina, Flamodip can be used alone or alongside other medications, such as beta-blockers or ACE inhibitors, to enhance its therapeutic benefits.
However, like any medication, Flamodip comes with potential side effects, including swelling, fatigue, and abdominal pain.
More severe risks, although rare, may involve significantly low blood pressure or even heart attack.
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