NAFDAC Orders Recall of Embacef 125 Powder Over Safety Concerns
The National Agency for Food and Drug Administration and Control (Dangerous! NAFDAC Counsel Drug Firms To Recall Embacef 125 Powder – NewsdishNG) has ordered the recall of Embacef 125 Powder for Oral Suspension following safety concerns raised about its quality.
In a public alert released on Sunday, the agency said the antibiotic, manufactured by Laborate Pharmaceutical in India and registered in Nigeria by Embassy Pharmaceutical and Chemicals Ltd, Lagos, was found to be substandard after a complaint was lodged at its Ekiti State office. The complaint revealed that two bottles of the reconstituted suspension solidified by the second day of use, prompting NAFDAC’s investigation.
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The agency confirmed that the product, which contains Cefuroxime Axetil and is used in treating a wide range of bacterial infections, posed safety risks and could compromise patient health. It warned that the use of substandard antibiotics may lead to treatment failure, worsening of infections, and the rise of antibiotic resistance.
The specific batch affected carries number PEDSE001, with a manufacturing date of February 2025, expiry date of January 2027, and NAFDAC Registration Number A4-9040. NAFDAC has directed the withdrawal of this batch and any other that may show similar defects, while ordering intensified surveillance to clear the product from circulation.
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The agency urged importers, distributors, retailers, healthcare professionals, and consumers to exercise vigilance and ensure medicines are purchased only from authorised sources. It further advised that any suspected cases of substandard or falsified medicines be reported to the nearest NAFDAC office, its toll-free line, or official reporting platforms.
NAFDAC also disclosed that the alert had been forwarded to the World Health Organisation’s Global Surveillance and Monitoring System to support international tracking and intervention.