Vaccines, Blood & Biologics
Rhо(D) Immune Globulin (Human) RhoGAM and MICRhоGAM Ultra-Filtered PLUS: Updated pH Specification Range
DATE FIELD NOTIFICATION INITIATED:
December 3, 2010
PRODUCT:
Rhо(D) Immune Globulin (Human) RhoGAM and MICRhоGAM Ultra-Filtered PLUS
Lots: RVP157A1 and RVP158A1
Product Name | Package Size | Product Code |
|---|---|---|
Rho(D) Immune Globulin (Human) RhoGAM Ultra-Filtered PLUS | 25 Syringe | 780525 |
Rho(D) Immune Globulin (Human) RhoGAM Ultra-Filtered PLUS | 5 Syringe | 780505 |
Rho(D) Immune Globulin (Human) RhoGAM Ultra-Filtered PLUS | 1 Syringe | 780501 |
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) RhoGAM and MICRhoGAM Ultra-Filtered PLUS has changed from 6.20 – 6.55 to6.20 – 7.00. The updated Package Insert will be available with product shipped beginning in the first quarter of 2011. Customers are asked to keep the notification letter with the product until the updated Package Insert is available.
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.
