Talecris Biotherapeutics, Inc. Recalls Rho(D) Immune Globulin (Human) Hyper RHO S/D, Mini-Dose

Rh_o(D) Immune Globulin (Human) Hyper RHO S/D, Mini-Dose

DATE RECALL INITIATED:

April 18, 2008

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Rh_o(D) Immune Globulin (Human); HyperRHO S/D, Mini-Dose

Lot Number: 26N7XX1
Expiration: June 29, 2009
NDC Number: 13533-631-06

MANUFACTURER:

Talecris Biotherapeutics, Inc.
Clayton, North Carolina

REASON:

This lot of HyperRHO S/D, Mini-Dose is currently testing less than the full potency of 250 IU/dose as labeled. The potency, as currently tested, is 204 IU/dose. This lot was at the full potency of 250 IU/dose through December 2007, the 18 month stability test point r|v#n. Customers are asked to immediately examine their stock to determine if they have any of the above mentioned lot and return product to Talecris Biotherapeutics, Inc.

tag: FDA Recall, Rho(D) Immune Globulin recall, HyperRHO S/D Recall, Talecris Biotherapeutics Recall