Newsroom.
GC Biopharma Initiates Voluntary Market Withdrawal of Three Lots of Product
Teaneck, NJ, July 30, 2026
As a precautionary measure, GC Biopharma Corporation is initiating a voluntary market withdrawal of the following lots due to the potential for an increased rate of hypersensitivity reactions associated with these specific lots. Hypersensitivity reactions are a known risk with immune globulin products.
Alyglo® (immune globulin intravenous, human-stwk) 10% Liquid
NDC Number: 61476-104-20
Lot Numbers: 394C25018, 394C25019, and 394C25020
Packaging Size: 20g/200mL
Expiration Dates:
- Lot 394C25018, expiration date May 01, 2028
- Lot 394C25019, expiration date May 08, 2028
- Lot 394C25020, expiration date May 11, 2028
- Please examine your stock immediately to identify inventory on hand, in transit, and at patient sites.
- Immediately quarantine lots 394C25018, 394C25019, and 394C25020.
- If you have product from these lots, please cease use immediately and do not dispense or administer from these lots.
- Return affected product to your point of purchase. Please contact your point of purchase directly to initiate the return process and to receive replacement product.
All clinical inquiries should be directed to GC Biopharma USA Medical Affairs at GCMedicalAffairs@gcbiopharmausa.com . To report an adverse event, please contact 1-833-426-6426, or email MedicalInfo@gcbiopharmausa.com , or e-fax 1-866-728-7855. Additionally, adverse events can be reported to www.fda.gov/medwatch , or by calling 1-800-FDA-1088.
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