On behalf of Magellan Rx Management, please see the most recent drug Class 1 recall notice.
Each FDA recall, warning, or alert is evaluated independently to determine the scope, classification and timeframe for response. The FDA defines recalls as follows:
- Class 1: A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
- Class 2: A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class 3: A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
- Market Withdrawal: Occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems would be a market withdrawal.
Under our URAC PBM Accreditation, Magellan Rx notifies members of Class I recalls and Market Withdrawals. In addition, for our NCQA accredited clients, Magellan Rx notifies members and prescribers of Class I and Class II recalls as well as Market Recalls, with the following exceptions as outlined in NCQA guidance:
Communication to members and prescribing practitioners is not applicable for:
- Withdrawals unrelated to safety issues.
- Recalled or withdrawn pharmaceuticals for which the organization is unable to identify affected members from the batch or lot numbers.
- Wholesale-only drug recalls and withdrawals.
