ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

07^th October, 2022 Dodoma

CONTAMINATED PAEDIATRIC FORMULATIONS OBSERVED IN WEST AFRICA

1. The Tanzania Medicines and Medical Devices Authority (TMDA) would like to notify the general public that it has been alerted by the World Health Organization (WHO) on the existence of four preparations highlighted below which have the potential of causing harm including death to users particularly children.
2. The concerned products are known by the following brand names - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
3. The labels of all these products indicate that the same were manufactured by one company based in India by the name of Maiden Pharmaceuticals Limited.
4. All samples of the products tested indicate that they contain toxic excipients namely diethylene glycol and ethylene glycol which can cause severe and serious adverse drug reactions including death to users.

   List of the products contaminated with Diethylene Glycol and Ethylene Glycol manufactured by Maiden Pharmaceuticals Limited (Haryana, India) identified in Gambia

   Product name	PROMETHAZINE ORALSOLUTION BP	KOFEXMALIN BABY COUGH SYRUP	MAKOFF BABY COUGH SYRUP	MAGRIP N COLD SYRUP
   Reported active ingredients	Promethazine	Pheniramine Maleate, Ammonium chloride, Menthol	Chlorphenamine Maleate,Phenylephrine HBR,Dextromethorphan syrup	Paracetamol Phenylephrine HCL,Chlorphenamine Maleate
   Lot number	ML21-202	ML21-199	ML21-203	ML21-198
   Mfg. date	Dec-21	Dec-21	Dec-21	Dec-21
   Exp. date	Nov-24	Nov-24	Nov-24	Nov-24
   Packaging language	English	English	English	English
   Available photograph

5. The purported products have been observed to be sold in The Gambian market (West African country) and according to WHO, the same have been implicated to be linked to atleast 66 deaths of children in this country.
6. TMDA would like to assure the public that these products are not on our market and that they had never been registered before to be used in Tanzania.
7. Nonetheless, the Authority has heightened its vigilance level through its post marketing surveillance system (PMS) to detect any product that might cross borders.
8. The public is urged to notify TMDA, in case such products would be detected anywhere in the country, through its headquarter (HQ) or zone offices, any nearby Regional and District Medical Officer’s offices or Police Station.
9. For more information please contact TMDA through its Toll Free Number 0800110084, HQ, Sub-HQ or zone offices located in Dodoma, Dar es Salaam, Mwanza, Geita, Arusha, Mbeya, Mtwara and Tabora.