NAFDAC has recalled a children’s cough syrup after its laboratory analysis showed it contains toxic components following its recent warning over counterfeit Tandak injection, an anti-bacterial jab. The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians against circulating suspected fake “Tandak Injections” nationwide. The agency warned Nigerians, particularly healthcare providers, against using the counterfeit “TANDAK injection 1.5g powder and water for injection,” saying the counterfeit is currently being sold to the unsuspecting public. The product is said to be manufactured by Intracin Pharmaceuticals, a human and veterinary health products manufacturer in Gujarat, India.
Tandak Injection, a co-formulation of Ceftriaxone 100mg and Sulbactam 500mg is prescribed to treat various bacterial infections in the body, such as gonorrhoea, syphilis, UTI infections, meningitis, and nosocomial infections brought on by susceptible bacteria. Tandak 1.5g injection works by inhibiting the spread and growth of the microorganisms. In a statement issued on Wednesday, 10 April, NAFDAC disclosed that the product was discovered in Gombe and reported to the agency by “Marcson Healthcare Ltd. – the Marketing Authorisation Holder (MAH).” NAFDAC advised against self-prescribing “Ceftriaxone+Sulbactam 1000mg/500mg Injection,” noting that it “should only be administered under the supervision of a healthcare professional.”
The agency has also recalled a children’s cough syrup after its laboratory analysis showed that the drug contains toxic components. Benylin Paediatrics Syrup, manufactured by Johnson & Johnson (J&J), is used to treat cough, fever, and other allergic conditions in children aged 2 to 12. However, NAFDAC’s analysis showed that it has a high level of Diethylene glycol, a chemical toxic to the body, and could have fatal effects when consumed. The Benylin Paediatrics syrup, according to NAFDAC, was found to cause acute oral toxicity in laboratory animals. The agency, in its statement, said, “It is notifying the public of the recall of one lot of Benylin Paediatrics syrup manufactured by Johnson & Johnson, following recent toxicity findings in the laboratory on the product.
NAFDAC said “Laboratory analysis conducted on the product showed that it contains an unacceptable high level of Diethylene glycol and was found to cause acute oral toxicity in laboratory animals. Diethylene glycol is toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.” Thus, instructing anyone in possession of the TANDAK 1.5g injection or the Benylin Paediatrics syrup to discontinue the sale or use and submit stock to the nearest NAFDAC office. It has also directed healthcare professionals and patients to report adverse events or side effects related to the use of these products to the nearest NAFDAC office. Anyone in possession of the above-mentioned product is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office.
The agency has said “If you witness any adverse reaction/event after the use of this product in any children, you are advised to direct such patients for immediate medical attention from a qualified healthcare professional.
