**Title: Urgent Recall: Bivigam Immune Globulin IV (Human) 10% – Visible Particles Detected**
**Date: April 5, 2013**
**Attention: Risk Managers, Infectious Disease Specialists, Health Professionals**
**Summary:**
Bivigam Immune Globulin Intravenous (10% Liquid, 100 mL Sterile Vial) from lot number 120016, with an expiration date of March 31, 2014, is under recall due to the observation of visible particles during a routine annual reserve inspection.
**Details:**
A critical recall has been issued for Bivigam Immune Globulin Intravenous (IGIV), owing to contamination concerns. This action comes after routine checks revealed the presence of particulate matter in specific product vials within lot number 120016. The potential presence of particles could lead to serious adverse health events if administered, including occlusive events in blood vessels, immune reactions, or other complications.
**Impact for Stakeholders:**
– **Risk Managers:** Ensure quarantine protocols are in place for the affected lot and coordinate with your supply chain to prevent administration of the affected product. Assess and mitigate any potential patient exposure risks.
– **Infectious Disease Specialists:** Verify that no patients under your care have been administered with the impacted lot. Remain vigilant for any adverse reactions stemming from past use of this batch.
– **Health Professionals:** Cease the use of B