Product recalls and market withdrawals happen on a daily basis. For consumers, they can prevent serious injuries or death, or they can simply provide information regarding a generally safe error in production. For this reason, it’s important to understand the distinctions between the two, as well as the different recall classifications, so you can make informed decisions on how to react.
The important distinction of a product recall is that it involves a government ordered removal from the market. Typically, a recalled product must present a significant threat to consumers due to a product defect, or violate a minimum federal or state safety standard.
Recalls are further distinguished by three classifications of severity:
Class I recall
A situation in which there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.
Class II recall
A situation in which use of or exposure to a 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 product is not likely to cause adverse health consequences.
In some cases, medical safety alerts are also considered recalls but they fall under a separate classification. They are issued in situations where a medical device may present an unreasonable risk of substantial harm.
By definition, a market withdrawal occurs when a manufacturer voluntarily stops producing or selling a product that has a minor violation not subject to FDA legal action. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal. Also, normal stock rotation practices, routine equipment adjustments, and repairs would all fall into this category.
One example of a market withdrawal is that of Merck’s arthritis drug, Vioxx. An ongoing trial confirmed that the medication led to an increased risk of heart attack and stroke but the FDA stated that Merck did not have to recall the product because the benefits outweighed the adverse affects. So Merck was not forced to remove the product from the market but they decided it was the best course of action anyway.
Has your company undergone a market withdrawal or product recall? If so, what differences stood out to you?
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