Recall
Rho(D) Immune Globulin (Human)
Hyper RHO S/D, Mini-Dose
DATE RECALL INITIATED:
April 18, 2008
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Rho(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. 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.
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.