Drug Safety Alerts

Octagam® 10% Liquid Preparation Withdrawal

2/09/2022

On February 9, 2022, Octapharma issued an expanded voluntary market withdrawal of Octagam® 10% Liquid Preparation NDC #68982-0850-05. This withdrawal was issued due to increased reports of hypersensitivity events, which could be a health hazard or safety risk to plan members using product affected by this recall.

This withdrawal affects lot numbers K139B8541 exp. 10/1/2024 and K140A8561 exp. 10/9/2024.

This withdrawal is an expansion of the withdrawal that was previously issued on January 21, 2022.

Effective immediately, 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 K139B8541 and K140A8561. Octapharma has determined, through consultation with the public health authorities at FDA, the most prudent course of action is to suspend further administration of this Octagam® from these production lots.

Hypersensitivity reactions, including urticaria, wheezing, and anaphylactoid-type responses, have been observed with all intravenous immune globulin products through published literature and post-marketing surveillance. The potential occurrence of these adverse events are listed in all manufacturer package inserts.

CVS Caremark Response: This product is not carried by the CVS Caremark® Mail Service Pharmacies.

For more information, please call Octapharma toll-free at 1-866-766-4860.. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.