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Drug Safety Alerts
Gamunex®-C 10% Voluntary Withdrawl
6/25/2021
On June 25, 2021, Grifols Therapeutics issued a voluntary withdrawal of one lot of Gamunex®-C 10% NDC # 13533-0800-71. 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 A1GKF00052 exp. 1/25/2024. The affected lot went into distribution on March 4, 2021.
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, please call Grifols Therapeutics toll-free at 1-800-520-2807 or visit www.gamunex-c.com. You may also call the United States Food and Drug Administration toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.