WHO Medical Product Alerts
Latest Updates and Full List of WHO Medical Product Alerts
Information Note Nitrosamine impurities
on 28/11/2019 at 8:25 am
Medicine Regulatory Authorities first became aware of the presence of the nitrosamine impurity, Nnitrosodimethylamine (NDMA), in products containing valsartan in July 2018. Valsartan is an Angiotensin II Receptor Blocker (ARB) and belongs to a family of analogue compounds commonly referred to as the sartans. Further nitrosamine impurities were subsequently detected in other medicines belonging to the sartan family, including: N-nitrosodiethylamine (NDEA), N -nitrosodiisopropylamine (NDIPA), N -nitrosoethylisopropylamine (NEIPA) and N -nitroso-N-methyl-4-aminobutyric acid (NMBA).
Medical Product Alert N° 11/2019 (English version)
on 17/10/2019 at 8:25 am
Falsified Amoxicillin + Clavulanic Acid products circulating in Haiti
Medical Product Alert N° 10/2019 (English version)
on 01/10/2019 at 1:25 pm
This Medical Product Alert relates to four confirmed falsified products: quinine sulphate circulating in Central African Republic and Chad and quinine bisulphate circulating in Uganda. It should be noted that this is the second WHO Medical Product Alert issued on the same batch number of falsified quinine bisulphate circulating in the African region. Please refer to the previous WHO Medical Product Alert N°2/2017 issued 27 July 2017. Quinine bisulphate and quinine sulphate are listed on the WHO Model List of Essential Medicines for management of severe malaria. This alert compiles details of four different falsified products that have been discovered at different times and locations over the past year. This repeated occurrence highlights the need for additional vigilance in Central and East Africa for such products that display common characteristics and distribution patterns. WHO was informed by a non-governmental organization (NGO) that this falsified quinine sulphate was found at patient level in the Central African Republic. At this stage, testing has not yet been conducted. Product details are listed in Table 1 below.
Medical Product Alert N° 9/2019 (English version)
on 20/08/2019 at 3:25 pm
Falsified Augmentin found in Uganda and Kenya
Medical Product Alert N° 8/2019 (English version)
on 16/07/2019 at 1:34 pm
This Medical Product Alert relates to 3 different falsified rabies vaccines (Verorab, Speeda, and Rabipur) and 1 falsified anti-rabies serum (Equirab) circulating in the Philippines. It is linked to the WHO Medical Product Alert N°1/2019 issued on 30 January 2019 regarding falsified Verorab rabies vaccines circulating in the Philippines. Rabies is a vaccine-preventable viral disease that is almost always fatal following the onset of clinical symptoms. Rabies is present worldwide, with over 95% of human deaths occurring in the Asia and Africa regions. Genuine Verorab, Speeda and Rabipur vaccines are used for pre-exposure vaccination or post-exposure prophylaxis. Genuine Equirab anti-rabies serum provides passive immunization against rabies. WHO recently received confirmation that falsified batches of Verorab, Speeda, Rabipur and Equirab were available at patient level in the Philippines. Investigations are ongoing, and laboratory analyses are being facilitated for available samples to determine their contents and better assess the risk to public health. At this stage, no adverse reactions attributed to the below mentioned falsified products have been reported to WHO. A rabies vaccine shortage is ongoing in the Philippines.
Medical Product Alert N° 7/2019 (English version)
on 24/04/2019 at 4:34 pm
Falsified meglumine antimoniate ampoules in Iran and Pakistan
Medical Product Alert N° 6/2019 (English version)
on 16/04/2019 at 5:15 pm
This Medical Product Alert relates to confirmed falsified hydrochlorothiazide that has been found to contain glibenclamide instead of hydrochlorothiazide, circulating in the WHO region of Africa. Adverse effects attributed to these products have been reported. Genuine hydrochlorothiazide is used as an antihypertensive and diuretic medicine, whereas glibenclamide is an antidiabetic medicine. In March 2019, WHO was informed by a nongovernmental organization in Cameroon that a medicine presenting as hydrochlorothiazide 50mg had caused hypoglycaemia in patients. Preliminary testing indicated that the product did not contain any of the stated active ingredient, hydrochlorothiazide, and glibenclamide had instead been identified. Verification with the stated manufacturer confirmed this product to be falsified. The local health authorities were informed of this incident.
Medical Product Alert N° 5/2019 (English version)
on 29/03/2019 at 9:15 am
This Medical Product Alert relates to the circulation of confirmed falsified Mencevax ACWY in the WHO region of Africa. Genuine Mencevax ACWY is used to prevent meningitis types A, C, W and Y. On 15 March 2019, the Ministry of Public Health in Niger issued a call for vigilance regarding the circulation of falsified Mencevax ACWY vaccines. This WHO medical product alert provides the details of those products which have been confirmed as falsified to date. Inquiries indicate that the supply chain route of these falsified vaccines includes other countries in West Africa: as such, increased vigilance is requested in all countries of the region, at all levels of the supply chain.
Medical Product Alert N° 4/2019 (English version)
on 21/03/2019 at 9:12 pm
This Medical Product Alert relates to the circulation of confirmed falsified DUnited KingdomORAL in the WHO region of South East Asia. Genuine Dukoral is a WHO pre-qualified oral cholera vaccine. WHO was recently informed by the manufacturer Valneva that 8000 falsified packs of the oral cholera vaccine Dukoral were distributed in Bangladesh. WHO country office and health authorities in Bangladesh have quarantined the falsified vaccines identified to date.
Medical Product Alert N° 3/2019 (English version)
on 22/02/2019 at 11:45 am
This Medical Product Alert relates to confirmed falsified versions of ICLUSIG 45mg circulating in the WHO Region of the Western Pacific. This is linked to the WHO Medical Product Alert N°2/2019 issued on 31 January 2019 regarding falsified ICLUSIG traded globally. Genuine ICLUSIG, the active pharmaceutical ingredient of which is Ponatinib Hydrochloride, is used to treat different forms of leukaemia. On 18 February 2019, WHO was informed that a wholesaler based in Malaysia had purchased the product ICLUSIG 45mg with batch number PR072875, presented in English language packaging. This specific product is referenced in the previous WHO Medical Product Alert N°2/2019 and is confirmed falsified.