TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

16^th Desemba, 2019

CLARIFICATION ON NOTICE ISSUED BY UGANDA NATIONAL DRUG AUTHORITY REGARDING RECALL FROM THE UGANDAN MARKET OF ALL MEDICINES MANUFACTURED BY ZHEJIANG RUIXIN PHARMACEUTICALS CO., LIMITED AND GRAND PHARMACEUTICALS LIMITED, CHINA

1. Tanzania Medicines and Medical Devices Authority (TMDA) would like to clarify to the public on a recent notice issued by the National Drug Authority (NDA) of Uganda directing dealers and distributors of pharmaceuticals to recall from Ugandan market all medicines manufactured by two Chinese based companies namely Zhejiang Ruixin Pharmaceuticals Co. Limited and Grand Pharmaceuticals Co. Limited.
2. The decision reached by National Drug Authority of Uganda (NDA) has come following recent inspection conducted at the above mentioned pharmaceutical manufacturers which resulted into failure of the companies to comply with good manufacturing practice (GMP) requirements.
3. The inspection of the factories was triggered by reports of falsified and substandard medicines purported to have been manufactured at the underlined facilities.
4. The Table below outlines products which have been recalled from the Ugandan market:-

   S/N.	Name of the medicine	S/N	Name of the medicine
   1.	Gentamycin 80mg /ml injection	6.	Aminophylline 25 mg/ml injection
   2.	Oxytocin 10 IU/ml Injection	7.	Atropine 25 mg/ml injection
   3.	Diclofenac 25 mg/ml injection	8.	Metoclopramide 5 mg/ml
   4.	Quinine 300 mg/ml injection	9.	Calcium gluconate 10% injection
   5.	Cloxacillin 500 mg injection	9.	Lidocaine 20 mg/ml injection

5. Following the decision made in Uganda, TMDA wishes to notify the public that, none of the above mentioned medicines have been registered in Tanzania and no permits had ever been issued before. A thorough inspection has also revealed that the concerned products are not circulating on the Tanzanian market.
6. TMDA inspectors have been alerted at all border points (including Mutukula border in Kagera) to remain vigilant including patrolling all unofficial entries commonly termed in Swahili as “Njia za Panya”.
7. The general public is further advised to report to TMDA offices any suspicious products they might come across or dispensed to them from any sources by scrutinizing on the labels the names of the above manufacturing facilities.
8. For further information or clarification on this matter, please contact TMDA Headquarter or Zone Offices located in Dodoma, Mwanza, Tabora, Mbeya, Arusha, Mtwara and Dar es Salaam.