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  1. Safety & Availability (Biologics)

2016 Biologics Recalls

2016 Biologics Recalls

Date Notification Brand Name Product Description Reason/Problem Company
8/11/2016 Voluntary Drug Recall Extension – Kogenate FS Antihemophilic Factor (Recombinant) For a complete list of lots, refer to Voluntary Drug Recall Extension – Kogenate FS Antihemophilic Factor (Recombinant) Bayer is issuing a follow-up to the communication sent to customers on July 21, 2016 regarding a voluntary recall of two lots of hemophilia A drug Kogenate® FS containing active ingredient manufactured before November 2015. Bayer HealthCare LLC
8/10/2016 Voluntary Drug Recall Extension – Helixate FS For a complete list of lots, refer to Voluntary Drug Recall Extension – Helixate FS CSL Behring is issuing a follow-up to the communication sent to customers on July 21, 2016 regarding a voluntary recall of two lots of hemophilia A drug Helixate® FS containing active ingredient manufactured before November 2015. Bayer HealthCare LLC
6/20/2016 URGENT Recall Extension for Leukotrap RC System with RC2D Filter All Lots of Leukotrap RC System with RC2D Filter (Re-Order Numbers 129-62 & 129-63)

Haemonetics Corporation is voluntarily recalling All Lots of its Leukotrap RC System with RC2D Filter (Re-Order Numbers 129-62 & 129-63), distributed since April 14, 2016.

Haemonetics has received further reports of higher than expected residual WBC associated with lot numbers beyond those described in its June 8, 2016 recall notification.

Haemonetics Manufacturing Inc.
6/8/2016 URGENT Recall for Leukotrap RC System with RC2D Filter Product ID: 129-62
Lot #: 1656076

Product ID: 129-63
Lot #: 1656083 and 1656084
Haemonetics Corporation is voluntarily recalling three lots of our Leukotrap RC System with RC2D Filter (Reorder #129-62 and 129-63).

Haemonetics has received reports of higher than expected residual WBC associated with lot numbers 1656076 (129-62) and 1656083 (129-63). Further, although they have not received reports, they have determined through their investigation that Reorder# 129-63, lot# 1656084 may also be affected by this issue and are recalling this lot as well.
Haemonetics Manufacturing Inc.
4/21/2016 URGENT – Voluntary Market Withdrawal - April 21, 2016: Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation] Lot Number: K551A8441
Expiration Date: December 17, 2017
Effective immediately, Octapharma USA Inc. is initiating a voluntary market withdrawal of Octagam 5% [Immune Globulin Intravenous (human)] 5% Liquid Preparation] that is labeled with lot number K551A8441. Octapharma USA, Inc
1/11/2016 Recall of RhoGAM Ultra-filtered PLUS [Rhₒ (D) Immune Globulin (Human)] Lot Number: RVP241B1 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. Ortho Clinical Diagnostics