Contaminated Medical Product Alert N°6/2022
Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup: contaminated product alert
WHO issued this alert on four substandard paediatric medicines identified in The Gambia and reported to WHO in September 2022. Laboratory analysis of samples of each product found unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. WHO said the products may have been distributed through informal markets to other countries or regions.1,2
- Issued
- 5 October 2022
- Issued by
- World Health Organization
- Name stated on packaging
- Maiden Pharmaceuticals Limited (Haryana, India), the stated manufacturer
- Genuine manufacturer's statement
- WHO said the stated manufacturer had not provided guarantees to WHO on the safety and quality of these products.
- Countries where detected
- The Gambia
Batches named in the alert
ML21-202 (Promethazine Oral Solution BP, manufactured Dec-21, expiry Nov-24), ML21-199 (Kofexmalin Baby Cough Syrup, manufactured Dec-21, expiry Nov-24), ML21-203 (Makoff Baby Cough Syrup, manufactured Dec-21, expiry Nov-24), ML21-198 (Magrip N Cold Syrup, manufactured Dec-21, expiry Nov-24), WHO said all batches should be considered unsafe until analysed by the relevant national regulatory authority.
Advice as stated
Do not use the listed products. Anyone who used them or had an adverse reaction should seek medical advice and report it to the national regulatory authority or pharmacovigilance centre. Regulators should remove the products from circulation and notify WHO.
Names printed on falsified products are not evidence that the named company made them. Where WHO or a regulator reports the genuine manufacturer's statement, it is shown.
Sources
- World Health Organization, Medical Product Alert N°6/2022: Substandard (contaminated) paediatric medicines (5 October 2022)
- World Health Organization, Medical Product Alert N°6/2022: annex (PDF) (5 October 2022)