Background
NDA is mandated to ensure that the population of Uganda has access to safe, effective and quality drugs
We received market complaints on quality of different pharmaceutical products. Some of the complaints were related to the occurrence of serious adverse events whereas other products had critical quality defects posing a risk to public health. Further investigations revealed that the manufacturing facilities of some of these drugs did not comply with Good Manufacturing Practices (GMP) requirements.
The National Drug Authority Board then decided to suspend and recall All Parenteral (Injectable) products manufactured by the facilities which were found to operate at unacceptable levels of GMP requirements. These include;
| No | Manufacturer | Name of Drug | Generic Name of Drug |
|---|---|---|---|
| 1 | JIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE, CHINA | R-ETHER | ARTEMETHER 80MG/ML |
| GMYCIN-80 | GENTAMYCIN SULPHATE 80MG/2ML | ||
| FALCIMAX-600 | QUININE DIHYDROCHLORIDE 600MG/2ML | ||
| ARTEMETHER INJECTION | ARTEMETHER 80MG/ML | ||
| QUININE DIHYDROCHLORIDE INJECTION | QUININE DIHYDROCHLORIDE 600MG/2ML | ||
| DICLOMAX-75 | DICLOFENAC SODIUM 75MG/ML | ||
| 2 | ANHUI CHENGSHI MEDICINE MANUFACTURE CO. LTD-INDUSTRIAL AREA, BENGBU CITY, ANHUI PROVINCE, CHINA | GENTAMYCIN INJECTION | GENTAMYCIN 80MG/2ML |
| ARTEMETHER INJECTION | ARTEMETHER 80MG/ML | ||
| VITAMIN B INJECTION | VIT B1 + VIT B2 + VIT B6 + NICOTINAMIDE + CALCIUM | ||
| DICLOFENAC SODIUM | DEXTROPANTOTHENATE DICLOFENAC 75MG/3ML | ||
| 3 | SHANDONG XIER KANGTAI PHARMACEUTICAL CO. LTD-PRIVATE ECONOMY ZONE, YANZHOU DISTRICT, SHANDONG, CHINA PR | CELLTRIAXON | CEFTRIAXONE 1GM |
| EXPEN | BENZYLPENICILLIN 1MU | ||
| PROCILIN | FORTIFIED PROCAINE BENZYLPENICILLIN 4MU |
NOTE: The names of drugs in the table above apply only to those drugs manufactured by the suspended manufacturing facilities.
Advise to Health workers.
1. Do not purchase any Injectable products manufactured by the companies in the table above. The license holders of these products have been instructed to recall the affected products and halt any importation.
2. Quarantine and return all of the affected products to their suppliers
3. To Report to NDA any adverse drugs reactions associated with similar products or any other product defects. Reports can be sent to any NDA office or by email to druginfo@nda.or.ug or calling 0414-255665 or by sending a message on WhatsApp to 0791415555
Thank you for your continued cooperation
Helen Byomire Ndagije
DIRECTOR PRODUCT SAFETY
Copy: Director Health Services, Clinical Services, Ministry of Health
Director Product Assessment and Registration
Director, Inspectorate and Enforcement
