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Recalls of U.S. Pharmaceutical Products Highest in Decade

FDA approved

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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Click here to view References:

1 Brooks K. U.S. Pharmaceutical Annual Recalls Set to Reach Highest Number in a Decade. Contract Pharma Dec. 19, 2023.
2 Ibid.
3 Ibid.
4 Ibid.
5 Manalac T. FY22 Drug Recalls Highest in Five Years: FDA Report. BioSpace June 22, 2023.
6 Ibid.
7 Ibid.
8 Ibid.

One Response

  1. You should see the never ending list of medical device recalls as well. Anyone placing blind trust in these systems needs a psychological examination more than whatever treatment or product these industries are selling you. Read through the list and see how many recalled products you or your family members have handled or used through the years. It’s practically guaranteed you’ll find at least one. Lists like this are the reason the complex managers seek to keep everyone’s attention focused on something else, usually with a never ending stream of solicitation and advertisements. When that does not work they’ll keep you busy focusing on individual lawsuits, legalese, and an infinite stream of legislative lobbyist type approaches. Because what they don’t want the general public being aware of, is how impossible it is for the FDA to successfully regulate anything. The FDA like other government institutions like the CDC have departed from their originally intended function, and now function as something else. These institutions are now merely place holders for big industry to provide a safeguard against torts claims. When enough complaints roll in, the FDA functions to deflect claims against manufacturers if enough people are harmed. They do practically nothing in terms of comparative torts litigation could accomplish, because manufacturers do not take enough care and caution to prevent the lawsuits from occurring in the first place, because they know the FDA and CDC is there to absorb and redirect all the peoples claims of harm to render them moot. Where as the alternative structure would be that all the harmed people would sue manufacturers directly and they would no longer be able to hide behind the FDA, and they would instead stop pushing so many dangerous products on a routine basis for fear of getting sued out of existence for causing such voluminous consumer harm. This same thing plays out again and again across the entire spectrum of dealings with government institutions. Which is why we libertarians say; Government should not be involved with these services. The governments purpose is to protect our liberties, not manager our lives, not manage our health care, not manage our lending institutions, not to provide insurance, not to provide insurance on money, not to print money, etc, etc, etc. Central planning never works. Every time the government becomes involved, nefarious players get involved as well, the scale of the systems become too massive to control, and people get hurt or financially harmed.

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

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