NATIONAL NEWS
NAFDAC Recalls Embacef 125 Powder for Oral Suspension
The National Agency for Food and Drug Administration and Control (NAFDAC) has issued Public Alert No. 029/2025, mandating the immediate recall of Embacef 125 Powder for Oral Suspension following quality and safety concerns associated with a specific batch of this antibiotic medication.
The recall notice was directed to Embassy Pharmaceutical and Chemicals Ltd in Lagos, the holder of the registration certificate, as well as Laborate Pharmaceutical India, the manufacturer of the product. This action was taken after a consumer complaint was filed at the NAFDAC office in Ekiti State. The complaint indicated that two bottles of the reconstituted suspension exhibited caking just one day after preparation, raising concerns about the product’s stability and effectiveness.
Following an investigation, NAFDAC confirmed the validity of the complaint, citing poor product quality that could pose health risks. Consequently, the agency has ordered the recall of the affected batch number PEDSE001, along with any other potentially compromised batches in circulation.
Product Details:
– Product Name: Embacef – 125 Suspension (Cefuroxime Axetil USP Powder for Oral Suspension)
– Manufacturing Date: February 2025
– Expiry Date: January 2027
– Batch Number: PEDSE001
– NRN: A4-9040
– Manufacturer: Laborate Pharmaceutical India, Panipat, India
– Registration Holder: Embassy Pharmaceutical and Chemicals Ltd, Lagos
NAFDAC warns that using substandard antibiotics, such as this product, could worsen health conditions, lead to treatment failure, or even result in death. Moreover, it can contribute to the global public health threat of antibiotic resistance.
Cefuroxime Axetil, the active ingredient in Embacef 125, is commonly prescribed to treat various bacterial infections, including bronchitis, urinary tract infections, gonorrhea, Lyme disease, and infections affecting the skin, throat, and sinuses.
The agency urges healthcare professionals, pharmacists, and consumers to review their inventories and immediately cease the sale or use of the affected batch.
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