Drug Safety Alerts

Octagam 10% 20GM Liquid Preparation Consumer-Level Withdrawal

10/27/17

On October 27, 2017, Octapharma issued a consumer-level withdrawal of 2 lots of Octagam^® 10% NDC # 68982-0850-04. This withdrawal was issued as a result of an increased number of reports of hypersensitivity events.

This recalls affects lot numbers K724B8541 exp. 06/14/2019 and K725A8541 exp. 06/23/2019.

Although there have been no reports of serious injury at this time, Octapharma has determined, through consultation with the public health authorities at the United States Food and Drug Administration (FDA), the most prudent course of action is to suspend further administration of Octagam 10% from these particular production lots. Hypersensitivity reactions, including hives and itching, 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 in all manufacturer package inserts.

CVS Caremark Response: Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies. To support member safety, CVS Caremark is sending letters to members who received this product through CVS Specialty Pharmacies and their physicians.

For more information about this withdrawal, please contact Octapharma at 1-866-766-4860, Monday through Friday, 8:30 am to 5:30 pm (ET). You may also contact the FDA at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at https://www.fda.gov/.