Class I recalls are the most severe and indicate that exposure and/or consumption of the drug will lead to adverse health effects or death.
Class II recalls refer to drugs that induce temporary and/or medically reversible health effects.
[2] Market withdrawals occur when a product has a minor violation that does not require FDA legal action.
Though not directly affiliated with the FDA, Mrs. Winslow's Soothing Syrup was denounced by the American Medical Association in 1911 via their article titled "Baby Killers."
Sons of DES mothers have displayed side effects like genital abnormalities, non-cancerous Epididymal Cysts, and infertility.
[7] Drugs and medical devices are typically recalled if the product is defective, contaminated, contains a foreign object, fails to meet specifications, mislabeled, or misbranded.
Level, notification, instructions, mechanics, impacts on economy, and individual consumer must all be considered in determining recall strategy.
Despite the seeming simplicity, the offending component is typically identified across multiple drug classifications, expanding the recall.
[9] Although incomplete, this list highlights some changes in United States government policy that have had an effect on drug recalls.
It allowed for financial compensation of the family should such threats come to light, and it increased vaccination safety precautions.
If the federal compensation is not sufficient or not granted, this act allowed patients to take legal action for vaccine injuries.
The Food and Drug Administration Modernization Act of 1997 was passed in order to streamline the FDA to meet standards of efficiency expected by the 21st century.
In regards to drugs, the act lowered the regulatory obligations of pharmaceutical companies, allowing them to rely on one clinical trial for approval.
Apropos to medical devices, private for-profit firms were allowed to review the products instead of the FDA.
[12] The 21st Century Cures Act would allow for faster approval of certain drugs, which could result in additional recalls.
The act would allow producers to submit data other than official clinical trials for consideration, such as case histories.