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In the interest of our members’ health and safety, IU Health Plans monitors alerts from the Food and Drug Administration (FDA) regarding prescription drug recalls and withdrawals. Drugs may be recalled by the FDA or withdrawn from the market by a manufacturer for a variety of reasons including safety and efficacy. IU Health Plans identifies and notifies members that may be potentially impacted when a prescription drug is recalled or withdrawn. In addition to these notifications, updates will be provided on this webpage for easy access for our members and providers.
The FDA classifies recalls according to the potential consequences the drug may cause. The FDA defines these classifications as follows:
Class I: Dangerous or defective products (including drugs) that predictably could cause serious health problems or death. Examples include: a label mix-up on a lifesaving drug
Class II: Products (including drugs) that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.
A drug manufacturer may call a voluntary market withdrawal to remove or correct a marketed drug that the FDA may consider to be in violation of FDA laws.
If you receive a notice that your medications may be impacted by a drug recall please act upon the notice and follow up with your prescriber and/or pharmacy as instructed. If you have additional questions about your prescription drug benefits please contact us.