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Drug Safety Alerts
Gamunex-C 10% Consumer Level Withdrawal
06/28/2019
On June 28, 2019, Grifols Therapeutics issued a consumer-level withdrawal of Gamunex®-C 10%.This withdrawal is being conducted due to a higher rate of allergic/hypersensitivity reactions, a smaller number of which were considered medically significant. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with IVIG products.
This withdrawal affects lot number A4GLD00502 exp. 04/06/22. No other lots are affected by this withdrawal. The affected lot went into distribution on May 21, 2019.
CVS Caremark® Response:
Please note: This product is not carried by the CVS Caremark® Mail Service Pharmacies.
For more information about this withdrawal, please contact Grifols Therapeuticsat 1-800-520-2807 or visit www.grifols.com. You may also contact 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.