The National Agency for Food and Drug Administration and Control (NAFDAC) has directed the immediate recall of Embacef 125 Powder for Oral Suspension from the Nigerian market following safety concerns.
In a public alert issued on Tuesday, NAFDAC said the decision was taken after a complaint received at its Ekiti State office revealed that two bottles of the reconstituted suspension caked after the first day of use.
Investigations confirmed that the antibiotic, produced by Laborate Pharmaceutical India and registered in Nigeria by Embassy Pharmaceutical and Chemicals Ltd, Lagos, posed quality and safety risks. The agency said the recall covered the affected batch and others with similar defects.
Embacef 125, which contains Cefuroxime Axetil, is commonly prescribed for infections such as bronchitis, gonorrhea, Lyme disease, and bacterial infections of the skin, ear, throat, tonsils, sinuses, and urinary tract.
NAFDAC warned that the use of substandard antibiotics could worsen health conditions, cause death, and contribute to the growing problem of antibiotic resistance.
Details of the recalled product include: Product name: Embacef 125 Suspension (Cefuroxime Axetil USP Powder for Oral Suspension), Batch number: PEDSE001, Manufacturing date: February 2025, Expiry date: January 2027, NRN: A4-9040
The agency urged healthcare professionals and consumers to report suspected cases of substandard or falsified medicines to the nearest NAFDAC office or call 0800-162-3322.
