In a proactive measure to safeguard public health, the National Agency for Food and Drug Administration and Control (NAFDAC) has ordered an immediate recall of Embacef 125 Powder for Oral Suspension.
This action comes after NAFDAC received a consumer complaint from Ekiti State, Nigeria, detailing a significant quality issue with the antibiotic. The complainant reported that the reconstituted suspension, which contains Cefuroxime Axetil, caked just one day after preparation, making it unusable and potentially ineffective. A public alert was issued.
“Public Alert No. 029/2025.
Notice to recall Embacef 125 Powder for Oral Suspension.
NAFDAC has issued a notification to Embassy Pharmaceutical and Chemicals Ltd, Lagos (Holder of Registration Certificate) and Laborate Pharmaceutical India, the manufacturer of Embacef 125 Powder for Oral Suspension, to recall its product following a complaint received reporting the caking of two bottles of the reconstituted suspension after the first day”.
NAFDAC conducted an investigation into the reported product and took some initial measures to stop the distribution across the country.
“The investigation of the complaint confirmed the product’s poor quality and safety concerns, as stated by the complainant. As a precautionary measure, NAFDAC has requested the recall of the affected batch and other batches with similar issues from the market.
Embacef 125 Powder for Oral Suspension contains Cefuroxime Axetil, an antibiotic used to treat infections caused by sensitive bacteria. It is effective against conditions such as bronchitis, gonorrhea, and Lyme disease. It can also be used to treat infections of the skin, ears, sinuses, throat, tonsils, and urinary tract”.
Details of the affected product according to NAFDAC is listed below:
PRODUCT DETAILS
• Product Name: Embacef – 125 Suspension (Cefuroxime Axetil USP Powder for Oral Suspension)
• Holder of Registration Certificate: Embassy Pharmaceutical and Chemicals Ltd, Lagos
• Product Manufacturer: Laborate Pharmaceutical India, E-11 Industrial Area, Panipat 132103.
• Manufacturing Date: 02/2025
• Expiry Date: 01/2027
• Batch Number: PEDSE001
• NRN: A4-9040
Citizens should be aware of the dangers of using fake and substandard products. Ensure you read labels and report anything suspicion as soon as possible.