NAFDAC Warns of Counterfeit Anti-Bacteria Injection and Deadly Cough Syrup

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning to Nigerians regarding the circulation of suspected fake “Tandak Injections” nationwide.

The agency advised Nigerians, especially healthcare providers, to avoid using the counterfeit “TANDAK injection 1.5g powder and water for injection,” as it is currently being sold to unsuspecting individuals.

This product is reportedly manufactured by Intracin Pharmaceuticals, a company from Gujarat, India.

Tandak Injection is a combination of Ceftriaxone 100mg and Sulbactam 500mg, prescribed for treating various bacterial infections such as gonorrhoea, syphilis, UTI infections, meningitis, and nosocomial infections caused by susceptible bacteria.

Tandak 1.5g injection acts by inhibiting the spread and growth of microorganisms.

NAFDAC revealed in a statement on Wednesday, 10 April, that the product was discovered in Gombe and reported by “Marcson Healthcare Ltd. – the Marketing Authorisation Holder (MAH).”

NAFDAC cautioned against self-prescribing “Ceftriaxone+Sulbactam 1000mg/500mg Injection,” emphasizing that it should only be administered under the supervision of a healthcare professional.

Recall of Benylin Paediatrics Syrup

As NAFDAC warns about the use of counterfeit Tandak injection, it also initiated a recall of a children’s cough syrup due to the presence of toxic components identified in laboratory analysis.

Benylin Paediatrics Syrup, produced by Johnson & Johnson (J&J), is utilized for treating cough, fever, and other allergic conditions in children aged 2 to 12.

However, NAFDAC’s analysis unveiled a high level of Diethylene glycol, a toxic chemical, in the syrup, which could have severe consequences if consumed.

NAFDAC noted that the Benylin Paediatrics syrup is associated with acute oral toxicity in laboratory animals.

The agency stated, “We are notifying the public regarding the recall of one lot of Benylin Paediatrics syrup manufactured by Johnson & Johnson, following recent toxicity findings in laboratory tests on the product.”

NAFDAC explained, “The laboratory analysis revealed an unacceptable high level of Diethylene glycol in the product, causing acute oral toxicity in laboratory animals.”

“Diethylene glycol is harmful to humans when ingested and can lead to fatal outcomes. Its effects may include abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental state, and acute kidney injury that could result in death.”

NAFDAC’s warnings

Following these revelations, NAFDAC instructed individuals with TANDAK 1.5g injection or Benylin Paediatrics syrup to discontinue their sale or use and submit stock to the nearest NAFDAC office.

Healthcare professionals and patients were directed to report any adverse events or side effects linked to these products to the nearest NAFDAC office.

“Anyone possessing the aforementioned product is advised to immediately halt its sale or usage and deliver the stock to the nearest NAFDAC office.”

“If you observe any adverse reaction/event after using this product on any children, kindly refer them for urgent medical attention from a qualified healthcare professional,” urged NAFDAC.

The agency informed that its zonal directors and state coordinators are tasked with monitoring and preventing the circulation of these products in their respective areas.

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It further stated that suspicions of substandard and falsified medicines can be reported to 0800-162-3322 or emailed to sf.alert@nafdac.gov.ng.

In Nigeria, the prevalence of substandard products continues to pose a threat to public health despite the enforcement efforts of authorities.

The distribution of fake or substandard medical items poses significant health risks as these products often do not adhere to regulatory standards, jeopardizing the safety of users.