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NAFDAC Warns Against Use Of Losartan Potassium Tablet, Automatic Transport Ventilators

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The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians of the recall of Losartan potassium tablet by its manufacturers.

NAFDAC has also warned healthcare providers to stop using some automatic ventilators because of the danger they pose to human health.
A statement by Prof. Moji Adeyeye, NAFDAC’s Director General, revealed that the tablet, manufactured by Hetero Labs Limited, Unit – I (API manufacturer), was recalled after detection of some dangerous impurity while also the ventilators had been recalled by the manufacturers.
She said that the tablet was used for the treatment of high blood pressure and congestive heart failure. “NAFDAC has been notified about the recall of Losartan potassium tablet 25 mg, 50 mg and 100 mg by Camber Pharmaceuticals.
“The recall was due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino Butyric Acid (NMBA), a possible process impurity or contaminant in an active pharmaceutical ingredient.
“Losartan Potassium, USP, is a prescription medication used in the treatment of high blood pressure and congestive heart failure and is packaged in 30ct, 90ct, 500ct, and 1000ct bottles. “N-Nitroso N-Methyl 4-amino Butyric Acid (NMBA) is a potential human carcinogen,’’ she said.
Adeyeye advised patients currently on the medication to meet their doctors for a possible change in medication.
“Patients should contact their doctor for further guidance and potential change of treatment before they stop taking the product.
“Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the nearest NAFDAC office,’’ she said.

Further, on the Ventilators,  “NAFDAC has been informed of the voluntary recall of Two e700, e600 and e500 Automatic Transport Ventilators by O-Two Medical Technologies Inc. “
These ventilators are being recalled because of the dangers they pose. “An improperly inserted screw in the ventilator screen may wear through the electrical insulation and create a short circuit that could lead the device to catch fire and injure the patient.
“Fires in oxygen-rich environments in a hospital or other health care facility pose increased risk of serious injury or death to both patients and device users,’’ she said.
 She explained that the products were designed for medical emergency use for both adults and children, and urged healthcare providers with any of the faulty products to return them to NAFDAC office.
 “The products, e700, e600 and e500 Automatic Transport Ventilators are emergency and transport ventilators designed for use before arriving at the hospital, in the hospital, between hospitals, and in transport settings. “
These ventilators are intended for use with adult, child and infant patients who are in cardiac arrest or respiratory distress and need breathing support.
“Stop using the device and immediately return any of the units that have undergone Thin-Film-Transistor (TFT) screen replacement or have had service performance in the screen area to nearest NAFDAC office. “
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the nearest NAFDAC office,’’ she said.
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