Drug Safety Alerts

Gamunex Consumer-Level Withdrawal

2/26/2021

On February 26, 2021, Grifols Therapeutics issued a consumer-level withdrawal of Gamunex®-C 10% NDC # 13533-0800-24 of lot numbers A1GLE01532 and A1GLE01542. On March 3, 2021, Grifols Therapeutics issued an additional consumer-level withdrawal of lot number A4GLE01482. These withdrawals are 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 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 https://www.gamunex-c.com/en/hcp.

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.