Drug Safety Alerts

Gamunex Consumer-Level Withdrawal

4/27/2021

On April 27, 2021, Grifols Therapeutics issued a consumer-level withdrawal of one lot of Gamunex®-C 10% NDC # 13533-0800-24. Gamunex is an intravenous immunoglobulin (IVIG) product. This withdrawal was initiated due to a higher rate of allergic/hypersensitivity reactions, a small number of which were considered medically significant. Hypersensitivity and allergic (anaphylactic/anaphylactoid) reactions are a known risk with IVIG products.

This withdrawal affects lot number A1GLE01602 exp. 11/19/2023. The affected lot went into distribution on December 23, 2020.

This higher rate of allergic/hypersensitivity reactions could be a health hazard or safety risk to patients using product affected by this withdrawal.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark® Mail Service Pharmacies. CVS Specialty is sending letters to members who received this product through CVS Specialty Pharmacies and their physicians.

For more information about the Gamunex®-C 10%, please call Grifols Therapeutics at 1-800-520-2807 or visit www.gamunex-c.com/en/hcp.

You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.