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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.