What led to Nigerian authorities flagging Indian paracetamol as toxic?

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Nigerian Authorities Flagged Indian Paracetamol as Toxic Due to Contamination Concerns

Nigerian authorities flagged an Indian-made paracetamol suspension, Para Clear, as toxic after samples exported to Liberia were found to contain the toxin ethylene glycol. The product also reportedly failed acute oral toxicity tests, with five laboratory animals reportedly dying during the assessment. These findings prompted the alert by Nigeria's National Agency for Food and Drugs Administration and Control (NAFDAC).
Ethylene Glycol Contamination Identified

The primary reason for the Nigerian authorities' alert was the detection of ethylene glycol in samples of Para Clear. This toxin was identified in the paracetamol suspension that had been exported to Liberia. Furthermore, the product reportedly exhibited a failure in acute oral toxicity requirements, evidenced by the recorded deaths of five laboratory animals during testing.
Product Quality Disputed by Manufacturer

Curis Lifesciences, the manufacturer of Para Clear, has contested the toxicity claims. The company stated that tests conducted by a private Indian laboratory indicated their product was of "standard quality." These tests reportedly found levels of ethylene glycol and diethylene glycol to be less than 0.1%, a threshold that the World Health Organisation (WHO) generally does not consider toxic.
Prior Concerns Over Similar Toxins

The flagging of Para Clear follows a series of incidents where Indian-made drugs were found to contain ethylene glycol and diethylene glycol. The WHO has previously linked these toxins to the deaths of numerous children in Gambia and Uzbekistan since the previous year. Ethylene glycol and diethylene glycol are industrial chemicals, commonly found in products such as brake fluid, and are not intended for human consumption.
Color Variation and Subsequent Testing

Prior to the toxicity flagging, Liberian authorities had initially intended to incinerate a batch of the paracetamol syrup due to a discrepancy in its color. The syrup was expected to be reddish brown but was found to be reddish pink. However, at the request of the medicine's local importer, the syrup was subsequently tested in Nigeria, leading to the official alert from Nigerian authorities regarding its toxic content.

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What led to Nigerian authorities flagging Indian paracetamol as toxic?

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