The UN agency said the batch of the syrup, branded Cold Out, was obtained from a location in Iraq and was submitted for laboratory analysis.

It was manufactured by Fourrts (India) Laboratories Pvt Ltd for Dabilife Pharma Pvt Ltd, and had higher than acceptable limit of contaminants diethylene glycol and ethylene glycol, WHO said in its medical products alert.

The batch had 0.25% of diethylene glycol and 2.1% of ethylene glycol, when the acceptable safety limit for both is no more than 0.10%, WHO said.

The agency said the manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product.

The companies did not immediately respond to Reuters’ requests for comments outside of business hours.

Cough syrups made in India were linked to deaths of at least 89 children in Gambia and Uzbekistan last year.

The Indian regulator had cancelled the manufacturing license of Marion Biotech, which had exported the syrups to Uzbekistan, and arrested some of their employees.

The company involved in Gambia, Maiden Pharmaceuticals, has denied that its drugs were responsible for the deaths in the country, and tests by an Indian government laboratory found no toxins in them.