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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Important Product Information – RECOMBINATE [Antihemophilic Factor (Recombinant)]

DATE NOTIFICATION INITIATED: October 27, 2011

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Product Code: 1502736 NDC#: 0944-2842-10

Product Lot Number

Labeled Kit Expiration Date

TRA11802AC

01/23/14

Product Code: 1503132 NDC#: 0944-2844-10

Product Lot Number

Labeled Kit Expiration Date

TRA11810AC

03/22/14

TRA11803AC

01/25/14

TRA11803AD

01/25/14

TRA11810AA

03/22/14

Product Code: 1503133 NDC#: 0944-2845-10

Product Lot Number

Labeled Kit Expiration Date

TRA11805AA

02/01/14

TRA11805AB

02/01/14

TRA11805AC

02/01/14

TRA11819AA

06/20/14

Product Code: 1502737 NDC#: 0944-2843-10

Product Lot Number

Labeled Kit Expiration Date

TRA11808AC

02/23/14

TRA11816AA

05/18/14

TRB11820AA

07/14/14

TRA11806AC

02/07/14

MANUFACTURER:

Baxter
Westlake Village, CA

REASON:

Baxter Healthcare Corporation is notifying customers of a labeling error affecting the expiration date of the Sterile Water for Injection that is packaged as a diluent with RECOMBINATE [Antihemophilic Factor (Recombinant)]. The Sterile Water for Injection label indicates that the shelf life is longer than what is currently approved, and is in conflict with the approved license expiry period. Baxter asks customers to continue using the RECOMBINATE product as labeled on the kit. There is no impact to the safety or efficacy of the product should the Sterile Water for Injection diluents be used at any time through the duration of the kits labeled shelf life (not the shelf life of the Sterile Water for Injection), as it meets all required specifications as labeled.


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.