When drug products are removed from shelves and taken off the market by the manufacturers, it is done so in accordance with a recall – either a voluntary or involuntary medicine recall. But what’s the difference?

Involuntary

When the FDA finds a flaw, potential hazard, or serious side effect in a medicine, they have the power to request a recall. A recall is a government issued request to retract a batch or entirely stop production of a defective product, specifically medication. 

Here’s how it works: the FDA ensures that over-the-counter medicine, prescription drugs, and vaccines are safe and effective. New drugs are evaluated by the FDA Center for Drug Evaluation and Research to ensure that health benefits outweigh any potential side effects. It is important to note that this branch of the FDA does not test drugs itself, the manufacturers run tests and send in their results, which are then reviewed by the FDA. It is at this point that the FDA decides if a drug is effective, high-quality, and safe. 

Voluntary

However in some cases, a company may recall a medication voluntarily—meaning they did not receive a request from FDA. 

For example: a company may discover potentially harmful effects or suspect a batch of medication has been contaminated during manufacturing. The company will then recall the product voluntarily before the FDA gets involved. Additionally, a retailer, such as CVS Pharmacy, can make the decision to remove a product from their shelves based on safety or other concerns for their customerswithout a recall request from the manufacturer or the FDA. 

Product recalls, either voluntary or involuntary, can be costly to a company and its reputation but are overall helpful in limiting liability for corporate negligence.

Do you have questions about the differences between voluntary and involuntary medicine recalls? Our experienced team at Scartelli Olszewski can help. 

 

Source: https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

https://www.fda.gov/drugs