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  5. Recall of RhoGAM Ultra-filtered Plus [Rhₒ (D) Immune Globulin (Human)]
  1. Safety & Availability (Biologics)

Recall of RhoGAM Ultra-filtered Plus [Rhₒ (D) Immune Globulin (Human)]

Recall of RhoGAM Ultra-filtered Plus [Rhₒ (D) Immune Globulin (Human)]

DATE RECALL INITIATED:

January 11, 2016

Product Name: RhoGAM Ultra-filtered PLUS [Rhₒ (D) Immune Globulin (Human)]

Lot number: RVP241B1
Expiration: May 31, 2017

MANUFACTURER:

Ortho Clinical Diagnostics
Raritan, New Jersey

DISTRIBUTOR:

Kedrion Biopharma, Inc.
Melville, New York

REASON:

This recall has been initiated due to a shipping error which resulted in the distribution of RhoGAM which was packaged with non-English labeling and which had not received clearance by CBER Product Release Branch; accordingly, the product is considered misbranded. Use of this product may result in an administration error or use where contraindicated, as the label and package insert are not written in the English language.

Consignees are asked to immediately examine their inventory and quarantine product subject to recall - syringes from RhoGAM Lot RVP241B1.


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.