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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.