Drug Recalls

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Drug Recalls

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Recalls of pharmaceutical products have surged in recent years...

Pharmaceutical companies occasionally need to recall—that is to say, remove—products from the market. While the reasons for product recalls vary, they are commonly related to packaging defects, contamination of a product, improper testing of a product, or inherent safety problems which could lead a product to harm a patient.

Those recalls are classified according to a three-tier system administered by FDA:

Class I Recall - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Class II Recall - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III Recall - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

FDA—not the companies—classify recalls. When a product is recalled by a company, it must submit to FDA various information, including the name of its product, its National Drug Code (NDC), its approval number, lot/unit number, its strength and route of administration, the extent of the recall, and a reason for the recall.

That last should, according to FDA's Guidance for Industry: Product Recalls, Including Removals and Corrections, include a detailed explanation of how the product is either defective or violative, how it affects the safety of the product, the nature of the defect and any information on how users should protect themselves in the meantime...

The overwhelming majority of the increase in recalls is being driven by a surge in Class II recalls, for which "use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences..."

It's difficult to blame any one factor for the rise in recalls, but one trend may be to blame for a sizeable portion of it. Beginning in 2012, FDA initiated a crackdown on compounding pharmacies after a massive and deadly outbreak of fungal meningitis which killed more than 60 people...

Source: Alexander Gaffney, RAC, Excerpt from Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns, Regulatory Affairs Professionals Society, August 11, 2014.

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Last Updated : Friday, November 13, 2020