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Medical Advisory #415: Baxter Announces Labeling Error on Sterile Water

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Medical Advisory #415: Baxter Announces Labeling Error on Sterile Water

November 16, 2011

Baxter Healthcare Corporation has sent a notice 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 was actually approved by the FDA.

Sterile Water for Injection is given an expiration date by the FDA based on how long the product is expected to maintain sterility (“shelf life”). After the expiration date, the vacuum may no longer be working, and bacteria may get in to contaminate the water. In the present situation, the actual expiration date of the Sterile Water for Injection is after the expiration date of the Recombinate it is packaged with, but not as long as the date stated on the bottle of Sterile Water for Injection. Thus there is no impact to the safety or efficacy of Recombinate if the Sterile Water for Injection diluent is used before the expiration date of the Recombinate.

Therefore it is safe to continue to use the Sterile Water for Injection that is packaged with Recombinate until the expiration date of the Recombinate.

The following are the NDC and Lot numbers of the Sterile Water for Injection vials:

NDC Number

Lot Number

Size

Expiration Date

0944284210

TRA11802AC

10 mL

01-23-2014

0944284410

TRA11810AC

10 mL

03-22-2014

0944284410

TRA11803AC

10 mL

01-25-2014

0944284410

TRA11803AD

10 mL

01-25-2014

0944284410

TRA11810AA

10 mL

03-22-2014

0944284510

TRA11805AA

10 mL

02-01-2014

0944284510

TRA11805AB

10 mL

02-01-2014

0944284510

TRA11805AC

10 mL

02-01-2014

0944284510

TRA11819AA

10 mL

06-20-2014

0944284310

TRA11808AC

10 mL

02-23-2014

0944284310

TRA11816AA

10 mL

05-18-2014

0944284310

TRB11820AA

10 mL

07-14-2014

0944284310

TRA11806AC

10 mL

02-07-2014

 

If you have any questions, please call Stericycle, Inc. at 1-888-UPDATE-U (1-888-873-2838).

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.

CHAPTERS: Please distribute this information to your membership.

Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The system is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge. To enroll in the PNS, please go online at http://www.patientnotificationsystem.org/ or else please call 1-888-UPDATE-U (1-888-873-2838).

This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommends that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.