THE National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert announcing the recall of one batch of Deekins Amoxycillin 500mg capsules following ‘reports’ of serious adverse drug reactions.
The affected batch, identified as 4C639001, was manufactured by Ecomed Pharma Ltd and marketed by DevineKings Pharmaceutical Ltd.
A statement by the organisation on Wednesday, December 11, via its X handle, noted that the recall was based on three cases of adverse drug reactions reported from a hospital where patients had been administered the affected medication.
According to NAFDAC, Amoxicillin, a penicillin-based antibiotic, is widely prescribed to treat bacterial infections, including tonsillitis, sinusitis, pneumonia, bronchitis, and ear, nose, throat, skin, and urinary tract infections.
The agency emphasised that adverse reactions to medications could be severe, potentially leading to hospitalisation, significant disability, or even fatal outcomes in extreme cases.
“An adverse reaction to drugs may be life-threatening, may require hospitalisation or prolongation of existing hospitalisation, result in persistent or significant disability or incapacity, or a birth defect or death in fatal cases,” the statement noted.
It further urged consumers who had used the product and experienced adverse symptoms to seek immediate medical attention.
It also advised healthcare providers, distributors, and patients to halt the distribution and use of the recalled batch, while encouraging persons with the product to return it to the nearest NAFDAC office.
“Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
“Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng,” the statement added.
The agency confirmed that the recall information would be shared with the World Health Organization’s Global Surveillance and Monitoring System (GSMS) to ensure broader awareness and monitoring.
Recurring concerns in product safety
The ICIR reports that this latest development adds to a growing list of safety alerts and recalls issued by the regulatory agency in recent months.
On Thursday, October 31, NAFDAC alerted Nigerians about the recall of Nivea Black & White Invisible Roll-On deodorant due to the presence of a prohibited chemical, Butylphenyl Methylpropional (BMHCA).
The chemical, flagged by the European Union’s Rapid Alert System (RAPEX), was said to pose serious health risks, including reproductive harm and skin irritation.
This was coming barely two months after the regulatory body also alerted the immediate recall of Dove Beauty Cream Bar Soap (100g) by European Union regulatory bodies following the discovery of a harmful chemical content in the product.
The soap, produced in Germany and sold under batch number 81832M 08 and bar code 8000700000005, contained Butylphenyl Methylpropional (BMHCA), a substance banned in cosmetics due to its potential health risks.
NAFDAC in a statement released September 9, said it had issued a public alert on August 30, 2024, warning that BMHCA, prohibited under the Cosmetic Products Regulation, posed serious risks, including reproductive harm and skin sensitisation.
It noted that the authorities in the European Union had already taken action to ban the product.
Usman Mustapha is a solution journalist with International Centre for Investigative Reporting. You can easily reach him via: umustapha@icirnigeria.com. He tweets @UsmanMustapha_M