- Contact Us
- News and Events
- Investor Relations
- Locations and Facilities
- Careers
- About Our Site
- Accessibility Statement
- Privacy Policy
- Terms and Conditions
- For Employers and Medical Plan Providers
- For Pharmacists and Medical Professionals
- Drug Lists
- Drug Safety Alerts
- Emergency Response
- Mail Service Numbers, Forms and Information
- Specialty Pharmacy Services, Information and Forms
- Electronic Prior Authorization Information
- Clinical Drug Information
- Clinical Programs and Health Management
- Clinical Publications
- FAQs For Pharmacists and Pharmacy Staff
- Pharmacy Help Desk
- FAQs For Prescribers and Office Staff
- Contact Us | Health Professionals Only
Drug Safety Alerts
Gamunex Consumer-Level Withdrawal
8/6/2021
On August 6, 2021, Grifols Therapeutics issued a voluntary withdrawal of several lots of Gamunex®-C 10%. Gamunex® is an intravenous immunoglobulin (IVIG) product. 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.
A complete list of the affected products and lot numbers is provided here.
This 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.