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Public Alert No. 0010/2019 – Alert on Falsified Meglumine Antimoniate Ampoules in Iran and Pakistan

 

May 1, 2019,

The National Agency for Food and Drug Administration and Control (NAFDAC) alerts the public, especially health care providers on the circulation of falsified Gulucatime injection in Iran and falsified Glucantime injection in Pakistan. Both falsified Gulucatime and falsified Glucantime claim to contain Meglumine Antimoniate.

Genuine Meglumine Antimoniate injection is used in the treatment of leishmaniasis.

In January 2019, the World Health Organization (WHO) was informed that a product called GULUCATIME was available at patient level in Iran. This product claims to be manufactured for Tillotts Pharma AG.

Verification by WHO confirmed that the product is falsified. The falsified GULUCATIME is labelled in English and French languages but displays spelling mistakes in both languages.

In March 2019, the WHO was informed that a similar product called GLUCANTIME was available at patient level in Pakistan.  This product also claims to be manufactured for Tillotts Pharma AG. The labelling on the product is in English language only. The product is confirmed to be falsified.

Tillotts Pharma AG has confirmed to WHO that they did not manufacture, sub-contract the manufacture, nor distribute these products anywhere in the world.

The details of the falsified Gulucatime and falsified Glucantime are:

Product Name Gulucatime1.5g/5ml solution for injection Glucantime1.5g/5ml solution for injection
Claims to be manufactured for Tillotts Pharma AG Tillotts Pharma AG
Labelled in English and French languages but displays spelling mistakes English language only
Batch Number II18-058 II-089
Manufacturing Date 11/2018 03/2018
Expiry Date 10/2021 02/2021

None of these products are reported to be in Nigeria.  NAFDAC implores all importers, wholesalers, distributors and retailers not to illegally import, distribute and sell the falsified Gulucatime injection and Glucantime injection.

Surveillance has been strengthened by NAFDAC at all ports of entry to prevent importation of the falsified Gulucatime and Glucantime injections. The agency has also heightened surveillance to prevent distribution and sales of the falsified products.

Health care providers and other members of the public are advised to be vigilant and contact the nearest NAFDAC office with any information on the falsified products.

Anybody in possession of the falsified Gulucatine and Glucantime injections should submit them to the nearest NAFDAC office.

Consumers are advised to report adverse events related to the use of medicines to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE for all Network ) or via pharmacovigilance@nafdac.gov.ng.

NAFDAC…….……..Safeguarding the Health of the Nation!!!