Falsified Medical Product Alert N°7/2019

GULUCATIME and GLUCANTIME (meglumine antimoniate) ampoules: falsified product alert

WHO issued this alert on two falsified leishmaniasis treatments found at patient level in Iran in January 2019 and Pakistan in March 2019. WHO said GULUCATIME was not manufactured in accordance with good manufacturing practices. The GULUCATIME packaging has spelling mistakes.¹

Health risk as statedNo explicit health risk statement on the alert page. WHO said there were no known adverse reactions reported to WHO at that stage.

Issued: 24 April 2019
Issued by: World Health Organization
Name stated on packaging: Labels state manufactured for Tillotts Pharma AG.
Genuine manufacturer's statement: WHO said Tillotts Pharma AG stated that it does not manufacture, sub-contract manufacture of, or distribute these products anywhere in the world.
Countries where detected: Iran, Pakistan

Batches named in the alert

Listed in Table 1 of the alert

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°7/2019: Falsified meglumine antimoniate ampoules (24 April 2019)