Octagam FDA Alerts

Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions

March 4, 2022 -- As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products.

1. Please examine your stock immediately to determine if you have any vials from these lots.
2. If you have product from these lots, please cease use immediately.
3. Return the affected product to the point of purchase to receive replacement product.

Octagam [Immune Globulin Intravenous (human)] 10 Percent Liquid Preparation]: Voluntary Market Withdrawal

ISSUE: Octapharma USA Inc. is initiating a voluntary market withdrawal of Octagam 10% [Immune Globulin Intravenous (human)] 10% Liquid Preparation] that is labeled with lot numbers K724B8541 & K725A8541. Although there have been no reports of serious injury at this time, Octapharma has determined, through consultation with the public health authorities at FDA, the most prudent course of action is to suspend further administration of octagam 10% from these particular production lots.

BACKGROUND: Lot numbers K724B8541 & K725A8541 are affected by this recall.

RECOMMENDATION: Distributors that received these lots of octagam 10% from Octapharma are asked to immediately quarantine these lots and contact Octapharma for return instructions.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[10/18/2017 - Voluntary Market Withdrawal Notice - FDA]
 

Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal - Risk of Thromboembolic Events

ISSUE: Octapharma USA Inc. initiated a voluntary market withdrawal of selected lots of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation as a result of an increased number of reported thromboembolic events, some of which were serious.

BACKGROUND: There were 9 thromboembolic events potentially associated with 7 of the lots that are being withdrawn from the market. Octagam is indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies.  See FDA Recall Notice for listing of affected lots.

RECOMMENDATION: Customers are asked to immediately quarantine the use of affected lots and to contact Octapharma’s Customer Service Department to arrange for product return.

[08/24/2010 - Recall Notice - FDA]