Drug Safety Alerts

Gamunex Extended Consumer-Level Withdrawal

3/23/2021

On March 23, 2021, Grifols Therapeutics issued a consumer-level withdrawal of Gamunex®-C 10% NDC # 13533-0800-24. This withdrawal was conducted 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 A3GLE01462 exp. 10/19/2023. The affected lot went into distribution on December 9, 2020.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark® Mail Service Pharmacies. This product is carried by the CVS Specialty® Pharmacies.

For more information, please call Grifols Therapeutics at 1-800-520-2807 or visit www.gamunex-c.com.

You may also call the United States Food and Drug Administration at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.