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Drug Safety Alerts
Gamunex-C 10% Consumer-Level Withdrawal
02/22/2019
On February 22, 2019, Grifols Therapeutics issued a consumer-level withdrawal of Gamunex®-C 10% NDC # 13533-0800-24.This withdrawal is being conducted due to a higher rate of allergic/hypersensitivity reactions, a small number of which were considered medically significant. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with IVIG products.
This withdrawal affects lot number A1GLC01372 exp. 11/20/21. No other lots are affected by this withdrawal.
CVS Caremark Response:
Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.
For more information about this withdrawal, health care providers may contact Grifols Therapeuticstoll-free at 1-800-520-2807 or visit www.grifols.com. You may also contact the United States Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.