Substandard and falsified medical product recalls in Zambia from 2018 to 2021 and implications on the quality surveillance systems.

ABSTRACT:

Background

Substandard and falsified (SF) medical products are removed from circulation through a process called 'product recall' by medicines regulatory agencies. In Zambia, the Zambia Medicines Regulatory Authority (ZAMRA) is responsible for recalling SF medical products from the Zambian market through passive and active surveillance methods. This study aimed to describe the prevalence of recalls of SF medical products and to analyse the frequently recalled therapeutic categories, dosage forms, categories of defects that led to the recalls and their sources with respect to the country of the marketing authorisation holder (MAH) or manufacturer.

Methods

We conducted a descriptive cross-sectional review of the product recalls issued by ZAMRA between January 2018 and December

SUBMITTER: Chabalenge B 

PROVIDER: S-EPMC9806395 | biostudies-literature | 2022 Jan-Dec

REPOSITORIES: biostudies-literature