US Pharmaceutical Market

2022: US recalls 5-year record number of defective drugs

At the end of 2022, a total of 912 low-quality drugs were recalled at 166 production sites in the United States. This is a record high in five years. Such data are provided on June 21, 2023 in the report of the Pharmaceutical Quality Administration (OPQ) as part of the Food and Drug Administration (FDA).

It is reported that in 2022, as in previous years, the most common reason for the reviews was deviations from good manufacturing practice. These are rules that establish the requirements for the organization of the production and quality control of medicines.

In the United States, a total of 912 low-quality drugs were recalled

More than a third - 37% - of all revocable programs are associated with several key reasons. These are, in particular, 130 cases dictated by non-compliance with the temperature regime; 100 campaigns due to violation of the storage conditions of medical products; 56 incidents due to non-compliance with production requirements; 51 recalls due to the manufacture of drugs using contaminated aids that were previously recalled from the supplier. In addition, 72 letters were sent to suppliers in 2022 with warnings related to non-compliance with good manufacturing practices.

The list of the most frequently recalled generic drugs included: acetaminophen-containing agents (tablets, liquids, suspensions), losartan with and without hydrochlorothiazide (tablets), fexofenadine/pseudoephedrine (tablets), oxymetazoline hydrochloride (nasal solution) and magnesium citrate (oral solution). Most of these products have been recalled due to non-compliance with temperature conditions or improper storage conditions in warehouses. The report emphasizes that the drug can degrade under such conditions, which negatively affects the shelf life, safety and/or efficacy of the drug.^[1]

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