Medical Product Warning no. 7/2019 (English version)

Counterfeit ampoules of meglumine antimony in Iran and Pakistan

These medical device warnings refer to two counterfeit products circulating in Iran and Pakistan, which are claimed to contain meglumine antimoniate for the treatment of leishmaniasis. Both counterfeit products are presented in pure glass ampoules and are falsely claimed to be made for Tillotts Pharma AG. The circulation of these counterfeit medical products has been confirmed in the WHO region of the Eastern Mediterranean.

Counterfeit Product no. 1: GULUCATIME In January 2019, WHO was notified that a product called GULUCATIME was available in patient-level patients. This product claims to be manufactured for Tillotts Pharma AG; WHO verification confirmed that the product was counterfeit. It is presented in cardboard boxes, each containing five ampoules. The packaging is in English and French but shows spelling errors in both languages. The product details are listed in Table 1 below.

Counterfeit Product no. 2: GLUCANTIME In March 2019, WHO was informed that a similar product called GLUCANTIME was available at the patient level in Pakistan. This product is also claimed to be made for Tillots Pharma AG and is confirmed to be fake. Available photos suggest that the label is in English only. The product details are listed in Table 1 below.

Table 1: Data on counterfeit GULUCATIME and GLUCANTIME products, subject to WHO medical device warnings no. 7/2019

The results of laboratory analyzes made possible by WHO show that GULUCATIME is not manufactured in accordance with good manufacturing practices.

Laboratory analysis of GLUCANTIME is underway. This medical product alert no. 7/2019 will subsequently be updated and published on WHO website once the results are known.

There are no known side effects reported to WHO at this stage attributed to the use of any of the two counterfeit products listed above.

The packaging or labels of the two products mentioned above (Gulucatime and Glucantime) indicate “made for Tillotts Pharma AG”. However, Tillotts Pharma AG has confirmed to WHO that they do not manufacture, subcontract or distribute them anywhere in the world.

PHOTOS OF CONFIRMED FALSIFIED MEGLUMIN ANTIMONIATE

Product 1: Gulucatime 1.5 g / 5 ml solution for injection, with serial number II18-058

Product 2: Glucantime, 1.5 g / 5 ml solution for injection, serial number II-089

WHO is demanding greater vigilance in the supply chains of countries likely to be affected by these false medical products. Increased alertness should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies and all other suppliers of medical devices.

If you own the above series, do not use them. If you have taken these counterfeit medical devices or if you suffer an adverse event or unexpected lack of efficacy, seek the advice of a qualified healthcare professional immediately and ensure that they report the incident to your local Ministry of Health / National Medicines Regulatory Authorities. National Pharmacovigilance Center.

All medical products must be obtained from credible and reliable sources. Their authenticity and condition should be carefully checked. If in doubt, seek the advice of a healthcare professional.

National health authorities ask you to notify WHO immediately if false medical devices are detected in their country. If you have any information on the production, distribution or supply of these medical products, please contact [email protected]

WHO Global Surveillance and Surveillance System
for substandard and counterfeit medical products

For more information, visit: http://www.who.int/medicines/regulation/ssffc/en/