![]() The FDA can directly and unilaterally demand the removal of medical devices, but it cannot do the same for medications. An injunction is issued to halt further manufacture or distribution. ![]() This legal action is pursued via the Food, Drug, and Cosmetic Act. In the rare case that a manufacturer refuses to do so, then the FDA can force the manufacturer to recall the product by statute. Instead, the FDA can only request that a manufacturer recalls a drug. The top recall causes are incorrect labeling, defective products, and incorrect potency. Common examples of contaminants that cause drug recalls were other drugs, heavy metals, bacteria, or fungi.Ĭontrary to public perception, the FDA does not have the authority to mandate a drug's withdrawal from the market directly. Īnother infamous recall occurred in 2012 when Pfizer recalled approximately 1 million packs of birth control pills due to incorrect packaging. ![]() The product caused 751 reported cases of fungal meningitis and 64 deaths. Historically, this incident was significant: it triggered a transfer of regulatory authority over compounded products from state pharmacy boards to the FDA. A striking example is the New England Compounding Center recall of injectable corticosteroids contaminated with fungal strains. Clinically important drug recalls occur approximately once per month in the United States. Illustrating the financial cost of recalls, Johnson and Johnson lost approximately $600 million in sales after closing a distribution site due to a recall. Moreover, the toll on human life has been substantial. FDA recalls have a significant financial toll on the healthcare system.
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