Vaccines, Blood & Biologics
Rhо(D) Immune Globulin (Human) MICRhоGAM Ultra-Filtered PLUS Lot MVP105A1: Updated pH Specification Range
DATE NOTIFICATION INITIATED:
November 22, 2010
PRODUCT / LOT NUMBER:
Rhо(D) Immune Globulin (Human) MICRhоGAM Ultra-Filtered PLUS
Lot Number: MVP105A1
Product Name | Package Size | Product Code |
|---|---|---|
Rho(D) Immune Globulin (Human) MICRhoGAM Ultra-Filtered PLUS | 25 Syringe | 780625 |
Rho(D) Immune Globulin (Human) MICRhoGAM Ultra-Filtered PLUS | 5 Syringe | 780605 |
Rho(D) Immune Globulin (Human) MICRhoGAM Ultra-Filtered PLUS | 1 Syringe | 780601 |
MANUFACTURER:
Ortho Clinical Diagnostics
Raritan, New Jersey
REASON:
Ortho Clinical Diagnostics (OCD) is including an update to labeling for Rho(D) Immune Globulin (Human) MICRhoGAM Ultra-Filtered PLUS to inform customers of a recent change in pH specification range. In the “Description” Section of the Package Insert, the pH range for Rho(D) Immune Globulin (Human) MICRhoGAM Ultra-Filtered PLUS has changed from 6.20 – 6.55 to6.20 – 7.00. Customers are asked to keep their notification letter with the product.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
