Falsified Medical Product Alert N°10/2019
Quinine Sulphate BP 300mg and 800mg, and Quinine Bisulphate 300mg B.P.: falsified product alert
WHO issued this alert on four falsified quinine products, used for severe malaria, found at patient level over the preceding year. Testing of the 800mg product, the Chad product and the Uganda product did not identify the expected active ingredient. The Uganda batch was reported by the Uganda National Drug Authority and was the subject of an earlier WHO alert in 2017.1
- Issued
- 16 October 2019
- Issued by
- World Health Organization
- Name stated on packaging
- Enitop Pharmaceutical Nig. Ltd. and Phamachim Bulgaria, stated on the packaging of the Central African Republic and Chad products. WHO reported that NAFDAC said Enitop is not a registered manufacturer and that Phamachim Bulgaria does not exist. The Uganda product names a manufacturer shown in a table image.
- Genuine manufacturer's statement
- WHO said the stated manufacturer of the Uganda product confirmed it did not make this falsified version. NAFDAC confirmed the Nigerian registration number on one pack is falsified.
- Countries where detected
- Central African Republic, Chad, Uganda
Batches named in the alert
7711006 (Quinine Sulphate 300mg, Central African Republic), 00952005 (Quinine Sulphate 800mg, Central African Republic), 7422 (Quinine Bisulphate 300mg, Uganda), 7711004 (Quinine Sulphate 300mg, Chad)
Advice as stated
Do not use the listed products. Anyone who has taken them or had an adverse event or lack of efficacy should seek advice from a health professional and report it to the national authorities. Obtain medical products only from authentic and reliable sources.
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°10/2019: Falsified Quinine Bisulphate and Quinine Sulphate (16 October 2019)