-
pv223 replied to the topic RECALLS in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
I feel that when the FDA orders a recall on products or medications, it is not because the product itself is bad but a recent batch that was rolled out that may have some sort of defect that could cause harm to people. For example, Levothyroxine is a generic medication for Synthroid, which is a thyroid medication. While the medication itself has been safe for years and millions of people take it, sometimes a batch of the medication at a certain strength ships out with a defect, which happened recently and we had to stop filling prescriptions that called for that medication. Another more recent example would be the recall of certain manufactures of Valsartan which were recalled because of some ingredients that could cause cancer. What I’m trying to point out here is that when the FDA initially approves a product, it is not that they always miss something but that defects happen over time and that they take control before things get out of hand.