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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Rho(D) Immune Globulin (Human); Hyper RHO S/D, Mini-Dose-Talecris Biotherapeutics, Inc

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.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Suite 200N/HFM-47

Rockville, MD 20852-1448