January 10, 2017
Car recalls are widespread and well known, but rarely does the general population hear about their medication recalls. Sometimes commercials will air during daytime television with a pharmaceutical recall, but rarely will a pharmacy call its patients and tell them about the recall.
What the public hears about a pharmaceutical recall is based on the class of the recall. The most serious recalls are Class I recalls, which are issued when the pharmaceutical has a high probability of leading to death. These are the ones that many see on commercials and that the news may cover.
The next recall classification is a Class II recall, which refers to pharmaceuticals which cause reversible or temporary effects but could not be lethal. This encompasses mishaps such as the 2016 failure of the birth control Gildess which caused extended periods and unintended pregnancies. This also encompasses the 2012 recall of a generic option for Lipitor, a cholesterol-lowering medication, was found to contain small glass particles. These are the most common recalls.
Class III recalls are the lowest recalls and cover any pharmaceuticals which won’t cause any side effects but are proven to be ineffective.
All forms of FDA recalls require the pharmaceutical to stop being sold, but only Class I recalls must be passed on to patients. Since patients aren’t technically “customers,” product recall laws don’t necessarily apply to the pharmaceuticals. This means that Class II pharmaceuticals must stop being sold, but patients who already have the medication and don’t need a refill for a while will probably continue to take the medication with proven side effects. The FDA has a list of all recalls and suggests that if your medication isn’t working correctly, you should check the list.
Many have a problem with this system because the side effects may not yet be noticeable enough to check, but the medication could still be harmful. Class II recalls cover a lot of ground, from a prolonged period to glass in pills, and the general may not hear about it until they go in for a refill.