Thirteen veterinary medicines recalled in 2020

In 2020, 13 veterinary medicines were recalled from the Irish market, according to the Health Products Regulatory Authority (HPRA), which published its 2020 annual report.

In the report, the HPRA said that there are certain cases where the withdrawal of a product is required to protect animal health and / or public health.

The 13 recalls in 2020 were described as a “significant increase” compared to 2019 when there were only seven.

Three of the recalls were related to stability issues; three related to non-compliance with specifications; two related to contamination problems; and two on design / non-compliance issues.

Two Use caution Notifications were also issued for veterinary medicinal products in order to reduce the risk of quality defects.

The HPRA’s inspection program is focused on ensuring compliance with relevant standards and laws, the HPRA said.

And in 2020 there were 16 good manufacturing practice (GMP) inspections at sites that manufacture / test veterinary medicines.

defects

In 2020, quality defects were reported or identified in 78 veterinary medicinal products, an increase of 15% compared to 2019.

The assigned risk classifications and the corresponding figures for the last two years are shown below.

year 2018 2019 2020
Critical quality defects 26th 10 12th
Significant quality defects 43 19th 36
Small quality defects 56 38 29
Number of reports not justified 0 1 1
Total number of quality defects 125 68 78

Image source: HPRA

The majority of reports – 55% – were submitted by pharmaceutical companies, including manufacturers, distributors and marketing authorization holders; 4% of the reports were received from other competent authorities.

The HPRA’s inspection program is focused on ensuring compliance with relevant standards and laws, the HPRA said.

And in 2020 there were 16 good manufacturing practice (GMP) inspections at sites that manufacture / test veterinary medicines.