Recolhimento de medicamentos no mercado brasileiro (2016-2020)

Abstract

This study aimed to analyze the drug recall scenario in the brazilian market from january 2016 to june 2020. The data were collected from ANVISA website, data on the drug, commercial name, therapeutic class, pharmaceutical form, dose / concentration, quantity of lots, company holding the registration, manufacturer company, recall communicated by ANVISA or company, the reason for recall, resolution number (RE), date, sale with or without medical prescription and regulatory category. After RE analysis, 414 recall was detected. The reasons found were quality deviation (n = 255), failure in fiscal analysis (n = 56), non-compliance with Good Manufacturing Practices (GMP) (n = 54), non-compliance with registration (n = 31) and failure in a stability study (n = 18). The therapeutic class that most recalled was anti-ulcer agents (n = 63), followed by antimicrobials (n = 52) and anti-hypertensive (n = 52). There were many recalls related to active pharmaceutical ingredients (n = 105), 84 of which (80%) due to nitrosamine impurity. Drugs with quality outside the specification were also frequent, being detected in fiscal analysis, in a stability study, in quality control and even by the receiving establishments. The lack of adequacy to GMP was probably where there was the greatest number of lots recall, which wasn't possible to estimate, as in these cases there is the recall of all valid lots and the suspension of manufacture, import, distribution, marketing and use of them, as long as there is no adaptation to GMP by the manufacturer. [resumo fornecido pelo autor]