Recalls of U.S. Pharmaceutical Products Highest in Decade
- by Rishma Parpia
- Published December 26, 2023
- Environment
Pharmaceutical product recalls in the United States are projected to reach the highest they have been in more than a decade, according to Sedgwick’s Quarterly Recall Index Report.1
Although the number of pharmaceutical product recalls in the U.S. decreased by 20.7 percent from the second quarter to the third quarter in 2023, the pharmaceutical industry is still expected to reach the highest number of product recalls per annum in more than 10 years. The first and second quarters of 2023 had a record number of recalls of—144 and 135 respectively. These numbers are well above the five-year average per quarter of 84.7 recalls, with the third quarter posting 107 pharmaceutical product recalls.2
Impurity, Instability Cited as Leading Causes of Recalls
Sedgwick’s Quarterly Recall Index Report also revealed that lack of sterility was the primary cause of pharmaceutical product recalls, which accounted for 45 of the recalls and affected 4.1 million products. One company’s products accounted for thirty of these recalls.3
The second cause for pharmaceutical recalls was ‘failed specifications,’ which was cited in 16 recalls, which included issues with impurities and product stability. Current Good Manufacturing Practice (cGMP) regulations were cited as a third reason for 13 recalls.
It has been observed that sterility issues, failed specifications and cGMP regulations are always the most common reasons for pharmaceutical product recalls. The report highlights that product recalls in the third quarter are believed to be due oversight because regulators have been working overtime due to a year of drug shortages.4
Most Production Sites are in the U.S.
The U.S. Food and Drug Administration’s (FDA) Fiscal Year 2022 Report on the State of the Pharmaceutical Quality recorded a significant increase in registered pharmaceutical product manufacturing sites in fiscal year 2022, as well as a significant increase in product recalls resulting in warning letters and surveillance inspections from the FDA.5
In 2022, the FDA said there were 4,814 registered manufacturing sites, which represented a 12 percent increase from 2018—of which 60 percent were making products with approved Biologics License and New Drug Applications. It was noted that a majority of the production facilities are in the U.S. although a significant number are in India, China and Germany and Canada.6
The growth in manufacturing sites was coupled with more FDA surveillance inspections amounting to 328 inspections in 2022, which was triple the number of inspections in 2021.7
The FDA also issued 28 import alerts and 72 warning letters in 2022. Import alerts allow the FDA to detain products from importers without a physical examination at the time of entry. These alerts are issued after the FDA has collected evidence to prove that the product, its manufacturer or shipper could be in violation of regulatory laws.
Most of the pharmaceutical product import alerts in 2022 were issued to Chinese and South Korean manufacturers. The FDA alerts for potential regulatory violations related to pharmaceutical products imported from China and South Korea respectively accounted for 43 percent and 36 percent of all 2022 import alerts.8
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