Gamunex-C lot withdrawn

According to the U.S. Food and Drug Administration (FDA), medications can be removed from the market in several different ways. Drug manufacturers can voluntarily issue both withdrawals and recalls, but the FDA can also request or require a recall. Here are the definitions for these actions, from least to most serious:

• Market withdrawal: The withdrawn medication has a minor violation that would not be subject to FDA legal action. The manufacturer removes the medication from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
• Class III recall: There is evidence of a manufacturing or distribution problem, but use of or exposure to the recalled medication is not likely to cause adverse health consequences.
• Class II recall: Use of or exposure to the recalled medication may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse health consequences is low.
• Class I recall: There is a reasonable probability that the use of or exposure to the recalled medication will cause serious adverse health consequences or death.

As a precautionary measure, the following lot of intravenous immune globulin (IVIG) have been voluntarily withdrawn by the manufacturer due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.

Affected products and lots

Bivigam

NDC number: 69800-6502-1
Lot number(s):  237447
Size: 5g    
Packaging: 50 ml vial
Expiration date(s): 06-30-2027
Reason: This voluntary withdrawal is being conducted due to the potential for an increased rate of allergic hypersensitivity type reactions associated with this specific lot. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products.
Contact: If you have any technical or clinical questions, please contact ADMA Customer Service at Customerservice@ADMAbio.com or call 1-888-458-4244.

Bivigam

NDC number: 69800-6503-1
Lot number(s):  321524 and 321724
Size: 10g    
Packaging: 100 ml vial
Expiration date(s):07-01-2027 and 08-31-2027
Reason: This voluntary withdrawal is being conducted due to the potential for an increased rate of allergic/hypersensitivity type reactions associated with this specific lot. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products.
Contact: If you have any technical or clinical questions, please contact ADMA Customer Service at Customerservice@ADMAbio.com or call 1-888-458-4244.

Gamunex-C

NDC number: 13533-800-40
Lot number(s):  B01J112733
Size: 40g 
Packaging: 400mL vial
Expiration date(s): 11-08-2027
Reason: This voluntary withdrawal is being conducted as a precautionary measure due to an increased rate of allergic/hypersensitivity type reactions associated with this specific lot. A small number of the reactions were considered medically significant. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products. This withdrawal is being conducted with the knowledge of the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research.
Contact: If you have technical or clinical questions, please contact U.S. Clinical Communications at (800) 520-2807.

Panzyga

Lot number(s): L319C8261 
Expiration date(s): 05-14-2026 

Grifols Therapeutics is initiating a voluntary withdrawal of two lots of XEMBIFY, 20% 4G VIAL. 

Xembify

NDC Number: 13533-810-20  
Lot Numbers:  B01J107803, B01J108133
Size: 4g    
Packaging: 20 mL    
Expiration Dates: 10-29-2027, 10-30-2027

Reason

This is to inform you that Grifols Therapeutics is initiating a voluntary withdrawal of one lot of XEMBIFY, 20% 4G VIAL as detailed below.

Grifols is committed to providing the highest quality medicines in the market. This voluntary withdrawal is being conducted due to the potential for an increased rate of allergic/hypersensitivity type reactions associated with this specific lot. Although Grifols has not received any reports of allergic/hypersensitivity type reactions related to this lot as of January 13, 2025, it is being withdrawn as a precautionary measure following an increased rate of reported hypersensitivity reactions in a separate lot made from the same source material. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products.

Other Information    

If you have any technical or clinical questions, please contact US Clinical Communications at (800) 520-2807.