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Drug Safety Alerts
Gamunex-C 10% Consumer-Level Withdrawal
12/31/2019
On December 31, 2019, Grifols Therapeutics issued a consumer-level withdrawal of Gamunex®-C 10% NDC # 13533-0800-71.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. Patients using the affected withdrawn product have been advised to discontinue the product and call their providers immediately.
This withdrawal affects lot number B3GKD00483 exp. 06/12/22. No other lots are affected by this withdrawal. The affected lot went into distribution on July 19, 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 Therapeutics at 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.