Medical product warning no. 6/2022: Substandard (contaminated) pediatric drugs | Catch My Job

Summary of warnings

This WHO Medical Product Alert relates to four substandard products, identified in The Gambia and reported to WHO in September 2022. Substandard medical products are products that do not meet quality standards or specifications and are therefore “out of specification”[1].

There are four products Promethazine Oral Solution, Cofexmaline cough syrup for babies, Makoff cough syrup for babies and Magrip N cold syrup. The listed manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the mentioned manufacturer has not given WHO guarantees about the safety and quality of these products.

Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as a contaminant. To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions.

Risks

Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal

Toxic effects can include abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental status, and acute kidney injury that can lead to death.

All batches of these products should be considered unsafe until analyzed by the relevant national regulatory authorities.

The substandard products listed in this warning are not safe and their use, especially by children, may result in serious injury or death.

Advice to regulatory authorities and the public

It is important to detect and remove these substandard products from circulation to prevent harm to patients.

WHO requires increased surveillance and diligence in the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised.

All medical products must be approved and obtained from authorized/licensed suppliers. The authenticity and physical condition of the product should be carefully checked. Seek advice from a healthcare professional when in doubt.

If you have these substandard products, please DO NOT use them. If you, or someone you know, has used these products or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre.

National regulatory/health authorities are advised to notify WHO immediately if these substandard products are detected in their country. If you have any information regarding the manufacture or supply of these products, please contact WHO via [email protected]

Click here for details and photos of non-standard products listed in Alert No. 6/2022.

Warning no. 6/2022 may be updated at a later stage as required.