Contaminated Medical Product Alert N°5/2023
NATURCOLD Syrup: contaminated product alert
WHO issued this alert on NATURCOLD syrup identified in Cameroon and first reported to WHO on 13 March 2023. A WHO-contracted prequalified laboratory found diethylene glycol at up to 28.6%, against an acceptable limit of 0.10%. WHO said the product may have entered informal markets in neighbouring countries.1,2
- Issued
- 19 July 2023
- Issued by
- World Health Organization
- Name stated on packaging
- FRAKEN INTERNATIONAL (England), given in the annex as the stated marketer. WHO reported that the UK MHRA confirmed no such manufacturer exists in the UK.
- Genuine manufacturer's statement
- WHO said the stated manufacturer had not provided WHO with any guarantees on safety or quality and inquiries into the product's origin were ongoing.
- Countries where detected
- Cameroon
Batches named in the alert
E22053 (expiry Feb-25)
Advice as stated
Do not use the affected products. Anyone who used them and had an adverse reaction should seek immediate medical advice. Report suspected adverse events to the national regulatory authority or pharmacovigilance centre.
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°5/2023: Substandard (contaminated) syrup medicines (19 July 2023)
- World Health Organization, Medical Product Alert N°5/2023: annex (PDF) (19 July 2023)