The Nationwide Company for Meals and Drug Administration and Management (NAFDAC) is alerting the general public concerning the recall of 1 batch of Juhel Folic acid 5mg x1000 pill, describing the product as substandard.
In accordance with an announcement revealed on the company’s official web site, the affected batch was recognized in the course of the Danger-Primarily based Submit Advertising and marketing Surveillance (PMS) carried out in February 2025.
Laboratory evaluation revealed that the product didn’t meet the required high quality requirements.
“The product was discovered to be substandard following laboratory exams, which confirmed low energetic pharmaceutical ingredient (API) content material,” NAFDAC said.
The company famous {that a} root trigger evaluation carried out by the producer Juhel Pharma Ltd. attributed the issue to a malfunction within the weight adjuster system of the tableting machine, which led to insufficient API content material. Consequently, the producer initiated a recall of the affected batch.
“The product is Juhel Folic Acid 5mg x1000 tablets, with Lot Quantity 0531, manufactured by Juhel Pharma Ltd., 35 Nkwubor Street, Emene – Enugu,” the assertion reads.
NAFDAC warned that administering substandard medicines poses important dangers to affected person well being and public well being.
“These dangers embrace poisoning, therapy failure, drug resistance, and even loss of life.
“Substandard medicines might include poisonous substances, incorrect elements, or incorrect dosages, resulting in extreme antagonistic results,” the company stated.
Folic acid is usually used to deal with or stop folate deficiency anaemia and is particularly important throughout being pregnant, because it helps the correct growth of the child’s mind, cranium, and spinal twine, serving to to stop neural tube defects equivalent to spina bifida.
In response to the problem, NAFDAC stated all zonal administrators and state coordinators have been directed to conduct surveillance and take away the substandard product from circulation of their respective areas.
The company urged distributors, retailers, healthcare professionals, and caregivers to be vigilant.
“All medical merchandise have to be obtained from approved or licensed suppliers. The authenticity and bodily situation of merchandise needs to be fastidiously checked,” NAFDAC said.
Healthcare professionals and shoppers are inspired to report any suspicion of substandard or falsified medicines to the closest NAFDAC workplace.
Nevertheless, NAFDAC expressed concern following a current alert from India’s Central Medicine Commonplace Management Group (CDSCO), which flagged a number of pharmaceutical merchandise as Not of Commonplace High quality (NSQ).
The declaration got here after CDSCO carried out laboratory evaluation on drug samples obtained from numerous gross sales and distribution factors throughout India. The affected medicine failed to satisfy required high quality requirements and had been formally designated as NSQ, signaling potential security and efficacy dangers.
NAFDAC famous that a few of the pharmaceutical corporations whose merchandise had been implicated within the CDSCO’s findings have subsidiaries, companions, or distributed merchandise in Nigeria.
Among the many corporations concerned are these with important presence or partnerships in Nigeria, together with companies like Abaris Healthcare Pvt Ltd, Alencure Biotech Pvt Ltd, Eurolife Healthcare Pvt Ltd, Well being Biotech Ltd, HIGGS Healthcare, Kamataka Antibiotics & Prescription drugs Ltd (KAPL), Laborate Prescription drugs India Ltd, Legend Industries, Martins & Brown Biosciences Pvt Ltd., Mascot Well being Sequence Pvt Ltd, Micron Pharmaceutical, Orison Pharma Worldwide, Rivpra Formulation Pvt Ltd, Sai Parenterals Ltd, Symbiosis Prescription drugs Pvt Ltd, Syncom Formulations (India) Ltd, and Zee Laboratories Ltd.
