Product Recall Classes I II III

March 7, 2008

The Difference Between Class 1, Class 2 & Class 3 Recalls

There are three classes of recall used by the FDA and USDA: Class 1, Class 2 and Class 3, often represented with Roman numerals I, II and III respectively. While both the FDA and USDA have their own definitions of product recall classes, they follow the same general rule - 1= most serious / dangerous, 2= potentially dangerous and 3 = least dangerous. Regardless of the classification level of a recall, consumers are advised to take each of them seriously and follow the instructions provided by the agency responsible for the recall.

FDA RECALL CLASSES DEFINED
When the US Food and Drug Administration (FDA) recalls a product, they classify it into three classes (much like USDA) based on the relative health risk:

Class I Recalls by the US Food and Drug Administration (FDA) are the most severe type of FDA recall. In a Class-I recall there is a potential for serious injury or death.

Class II Recalls are issued on products that have a lower chance of causing major injuries or death, but where there is still the possibility of serious enough adverse events to have irreversible consequences.

Class III Recalls are not very likely to cause adverse health consequences, but there is still a chance and therefore the product is being recalled.

USDA RECALL CLASSES DEFINED
When the United States Department of Agriculture (USDA) Recall Committee recommends a recall, they classify the recall into three classes (much like FDA) based on the relative health risk:

Class 1 USDA recalls are the most serious and involve a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death.

Class 2 USDA recalls involve a potential health hazard situation in which there is a remote probability of adverse health consequences from eating the food.

Class 3 USDA recalls involve a situation in which eating the food will not cause adverse health consequences.

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Written by E. Sizemore · Filed Under US News, USRCN Editorial 

Comments

3 Responses to “Product Recall Classes I II III”

  1. Peggy Clement on May 1st, 2008 3:40 am

    I have been on digitek for several years and have been feeling quite ill for quite some time, now I know why. Thanks to the news I found out what was going on. However, I did get in touch with my pharmacy and they will send me some more medecine and I am to mail my present prescription back to the pharmacy. I like others would like to know how long this has been sent to me and whose hands will be slapped.

  2. mary miller on May 7th, 2008 10:57 pm

    What the f****?! My sister has had 3 major heart procedures in 1 month - symptoms suspiciously like digoxin overdose. Her heart wasn’t in good shape to begin with,hence the digoxin treatment, and now I hear it may have been caused by this! My immediate advice to her was”get a lawyer!” How hard can it be to have a serious medication like this double checked. Mary Miller

  3. Tami-Jo Pons on May 9th, 2008 9:08 am

    Two heart attacks within 3 weeks…feeling very weak and strange after the last

    one…never got back to feeling well..so Dr. doubled my dose of Digitex in March.
    ..
    Would not have known about this re-call except for letter from Wal-Mart Pharmacy

    received today.

    Has the profits made by the drug companies blinded them to the horrors and devastation their lack of quality control is causing to the American People ?

    Do not have to wait for a Chinese product to do us in, our own American

    companies are doing a great job…How may deaths already reported ????

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