Vaccines, Blood & Biologics

BAXJECT II Hi-Flow device packaged with ARALAST NP [Alpha1-Proteinase Inhibitor (Human)]

DATE CORRECTION INITIATED:

May 9, 2011

PRODUCT / LOT NUMBER / EXPIRATION DATE:

ARALAST NP [Alpha1-Proteinase Inhibitor (Human)], packaged with BAXJECT II Hi-Flow

Affected Product Listing:

ARALAST NP 0.5G 25ML: Product Code 1502959, NDC# 0944-2812-01

ARALAST NP 0.5G 25ML: Product Code 1502959, NDC# 0944-2812-01
Lot NumberExpiration Date
VNB5K015A-AA03/31/12
VNB5K015A-AB03/31/12
VNB5K015A-AC03/31/12
VNB5K015A-AD03/31/12
VNB5K015A-AE03/31/12

ARALAST NP 1.0G50ML: Product Code 1502960, NDC# 0944-2822-02

ARALAST NP 1.0G50ML: Product Code 1502960, NDC# 0944-2822-02
Lot NumberExpiration DateLot NumberExpiration DateLot NumberExpiration Date
VNB5K014-AA03/31/12VNB5K041-AC08/31/12VNB5K057-AA11/30/12
VNB5K021-AA04/30/12VNB5K042-AA08/31/12VNB5K058-AA11/30/12
VNB5K022-AA04/30/12VNB5K043-AA09/30/12VNB5K059-AA11/30/12
VNB5K023-AA04/30/12VNB5K044-AA09/30/12VNB5L001-AA12/31/12
VNB5K028-AB05/31/12VNB5K047A-AA09/30/12VNB5L001-AB12/31/12
VNB5K029-AA05/31/12VNB5K047B-AA09/30/12VNB5L002-AA12/31/12
VNB5K031-AA06/30/12VNB5K048-AA10/31/12VNB5L003-AA12/31/12
VNB5K032-AA07/31/12VNB5K049-AA10/31/12VNB5L004-AA01/31/13
VNB5K033A-AB07/31/12VNB5K050-AA10/31/12VNB5L005-AA01/31/13
VNB5K033B-AB07/31/12VNB5K051-AA10/31/12VNB5L006-AA01/31/13
VNB5K035-AA07/31/12VNB5K051-AB10/31/12VNB5L007-AA01/31/13
VNB5K037-AB07/31/12VNB5K052-AA10/31/12VNB5L008-AA01/31/13
VNB5K039-AA08/31/12VNB5K053-AA10/31/12VNB5L009-AA02/28/13
VNB5K040-AA08/31/12VNB5K056-AA11/30/12VNB5L009A-AA02/28/13
VNB5K040-AB08/31/12  VNB5L010-AA02/28/13

MANUFACTURER:

Baxter AG
Vienna, Austria

REASON:

Baxter is requesting that customers discontinue use of the BAXJECT II Hi-Flow device packaged with ARALAST NP [Alpha1-Proteinase Inhibitor (Human)], and discard any unused devices.

This action is being taken as a precautionary measure after Baxter received reports that particle formation has been observed in the reconstituted solution when the BAXJECT II Hi-Flow device is used in combination with ARALAST NP. Product distributed with a double-ended transfer needle and 20 micron filter is not impacted by this action. It is important to note that ARALAST NP continues to be safe, and should be used with an alternative means of reconstitution.

Customers are requested to discontinue use of the BAXJECT II Hi-Flow device for reconstitution of ARALAST NP and discard any unused devices.ARALAST NP may be safely reconstituted and administered using alternative transfer devices and filter needles. Baxter will replace the BAXJECT II Hi-Flow device with a Covidien double ended needle to be used in place of BAXJECT II Hi-Flow.When pooling, Baxter recommends use of filter needles with pore size of 20 microns or less in conjunction with a commercially available 5 micron inline filter, as used in the administration of other Alpha1-Proteinase Inhibitor products.


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.

Page Last Updated: 08/21/2014
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