Medical Product Warning no. 10/2019 (English version)

Counterfeit quinine bisulfate circulating in Uganda and quinine sulfate circulating in the Central African Republic and Chad

These medical product alerts refer to four confirmed counterfeit products: quinine sulfate circulating in the Central African Republic and Chad and quinine bisulfate circulating in Uganda. It should be noted that this is the second WHO medical device alert issued on the same batch of counterfeit quinine bisulfate circulating in the African region. Please see above WHO medical device alert no. 2/2017 issued July 27, 2017. Quinine bisulfate and quinine sulfate are listed on the WHO Model List of Essential Medicines for the Suppression of Severe Malaria. This alert compiles details of four different counterfeit products that have been detected at different times and locations over the past year. This recurrence emphasizes the need for additional vigilance in Central and Eastern Africa for such products displaying common characteristics and patterns of distribution.

1. Quinine sulfate BP 300mg identified in Central African Republic

The WHO has informed a non-governmental organization (NGO) that this counterfeit quinine sulfate has been found at the level of patients in the Central African Republic. At this stage, testing has not yet been conducted. The product details are listed in Table 1 below.

Table 1: Counterfeit quinine sulfate BP 300mg data subject to WHO medical device alert No. 10/2019

With regard to the above manufacturer, it should be noted that:

• Packaging indicates the product that will be manufactured by “Enitop Pharmaceutical Nig. Ltd. ”The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria has confirmed that“ Enitop Pharmaceutical Nig. Ltd. ”is not registered as a manufacturer.
• The packaging indicates the product to be manufactured by Phamachim Bulgaria. This manufacturer does not exist.

It should also be noted that:

• At this stage, no NHS have been reported.
• The packaging is in French, but shows a number of inconsistencies.
• The registration number provided on the packaging refers to the National Food and Drug Administration (NAFDAC) in Nigeria. NAFDAC confirmed that it was fake.

2. QUININE SULPHATE BP 800mg identified in Central African Republic

The WHO recently informed a non-governmental organization (NGO) that this counterfeit quinine sulfate has been found at the patient level in Central Africa. Preliminary tests showed that the product did not contain any of the active ingredients listed. The product details are listed in Table 2 below.

Table 2: Data on counterfeit quinine sulfate BP 800mg, subject to WHO medical device alert no. 10/2019

With regard to the above manufacturer, it should be noted that:

• The packaging indicates the product to be manufactured by Phamachim, Bulgaria. This manufacturer does not exist.

It should also be noted that:

• Thin layer chromatography did not identify the expected active ingredient.
• At this stage, no NHS have been reported.
• The packaging is in French, but shows a number of inconsistencies.
• The registration number provided on the packaging refers to the National Food and Drug Administration (NAFDAC) in Nigeria. NAFDAC confirmed that it was fake.

3. QUININ BISULPHATE 300mg. Boiling point identified in Uganda

The WHO recently informed the Uganda National Medicines Authority that counterfeit quinine bisulfate is at the patient level in Uganda through routine post-marketing surveillance of the quality of medicinal products on the market. Samples were sent for laboratory testing and the results were distributed to WHO. The product details are listed in Table 3 below and are contained in Report of the National Medicines Agency of Uganda

Table 3: Details of counterfeit quinine bisulfate 300 mg. B.P., subject of WHO medical device alert no. 10/2019

The above manufacturer confirmed that:

• They did not produce this counterfeit version.
• The variable details on the product label do not match the original manufacturer’s information.

It should also be noted that:

• Laboratory analysis did not identify the expected active substance.
• At this stage, no NHS have been reported.
• There are inconsistencies in labeling and packaging, including spelling mistakes.

4. Quinine sulfate BP 300mg identified in Chad

The WHO has informed a non-governmental organization (NGO) that this counterfeit quinine sulfate has been found at the patient level in Chad. Preliminary tests showed that the product did not contain any of the active ingredients listed. The product details are listed in Table 4 below.

Table 4: Counterfeit quinine sulfate BP 300mg data subject to WHO medical device alert No. 10/2019

With regard to the above manufacturer, it should be noted that:

• Packaging indicates the product that will be manufactured by “Enitop Pharmaceutical Nig. Ltd. The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria has confirmed that “Enitop Pharmaceutical Nig. Ltd. ”is not registered as a manufacturer.
• The packaging indicates the product to be manufactured by Phamachim Bulgaria. This manufacturer does not exist.

It should also be noted that:

• Thin layer chromatography did not identify the expected active ingredient.
• At this stage, no NHS have been reported.
• The packaging is in French, but shows a number of inconsistencies.
• The registration number provided on the packaging refers to the National Food and Drug Administration (NAFDAC) in Nigeria. NAFDAC confirmed that it was fake.

Photos and tips for the public are available below.

Quinine Sulfate BP 300mg, series 7711006 identified in Central African Republic

Quinine Sulfate BP 800mg, batch number 00952005 identified in Central African Republic

QUININ bisulfate 300mg. B.P., series 7422 identified in Uganda

QUININ SULPHATE BP 300mg, series 7711004 identified in Chad

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 products, 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/