The Patient Notification System (PNS) informs people when a blood product is withdrawn or recalled.

The Patient Notification System is being administered by an independent third-party vendor, the National Notification Center, and is restricted from revealing the identity of those individuals who have registered to receive information.

Participating companies involved in the system are:
Alpha Therapeutics
Baxter Healthcare
Bayer Corporation
CSL Behring
Genetics Institute
The American Red Cross

Register with the Patient Notification System now!

The system is available:
By phone: 888-873-2838 (888-UPDATE-U)
Online Enrollment: www.patientnotificationsystem.org
Fax registration forms to: 1-800-442-2906
Mail registration forms to: 
         National Notification Center 
         20 N. Meridian Street, Suite 300
         Indianapolis, IN 46204
 

Register now to be directly notified an informed
when a blood product is withdrawn or recalled.


URGENT: BIOLOGIC RECALL INFORMATION

Initiated by: Baxter Healthcare
Event Id: 151
Event Date: 03-14-2012

Therapy

Gammagard Liquid [Immune Globulin Intravenous (Human)] 10%
NDC Number: 0944-2700-06
Lot Number: LE12LG70AC
Size: 20g
Packaging: vial
Expiration Date: 11-25-2014

Reason

Baxter Healthcare Corporation is voluntarily recalling lot LE12LG70AC of GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)] 10%, 20g size, product code 1502797, NDC# 0944-2700-06. This recall is being conducted as a precautionary measure due to a labeling error noted on the product vial label and unit carton. The labels on the unit carton and product vials indicate an incorrect manufacturing date and expiry date.

• Incorrect Manufacturing Date: November 25, 2011
• Incorrect Expiration Date: November 25, 2014

• Correct Manufacturing Date: November 5, 2011
• Correct Expiration Date: November 5, 2014

The Food and Drug Administration has been notified of this action

Considering the information noted above, the medical assessment into this issue concluded that this labeling error poses negligible safety risk to the patient. This labeling error has no impact on the functionality of the product. Furthermore, stability data indicates the difference of 20 days between the correct expiry date and the printed expiry date has no impact on the product quality. Therefore, if you have already used this product no action is required. However, if you still have any inventory of this product lot, we are asking you to return the product.

Action

  1. Please check all product labels against the affected lot number.
  2. Do not take this product. Return affected recalled lots to the point of purchase to receive  replacement product.

Other Information

If you need assistance, please call Stericycle, Inc. at 1-888-873-2838.



MEDICAL ADVISORY #415

Baxter Announces Labeling Error on Sterile Water

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.

Please continue to use the RECOMBINATE product as labeled on the kit. 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.

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
 

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

You must sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. To enroll in the PNS, please call (888) UPDATE-U or go online at www.patientnotificationsystem.org
 

HANY provides this material for your general information only.    HANY does not engage in the practice of medicine, nor does it advocate or recommend specific medical treatments.  You should consult your physician or local treatment center before pursuing any course of treatment.



MEDICAL ADVISORY #414


Warning About Use of Non-Sterile Alcohol Wipes

In January 2011, NHF issued a Medical Advisory (#412) about a recall of non-sterile alcohol wipes produced by one company, Triad. In April, the FDA forced this company to close. Now, additional infections have occurred in patients using non-sterile alcohol wipes manufactured by another company, Pacific Disposables International (PDI). This company has also been required by the FDA to recall their products. Both of these companies package their products under their own label and under other companies’ labels.

At this time, it appears prudent to recommend that all individuals who have alcohol wipes or other prep pads/swabs in their home examine the individual packages to see if they contain the word “Sterile.” This includes wipes that are packaged with factor or other IV preparation kits.  If the word “sterile” does not appear on the package, there is no way to determine if they are in fact sterile or not. Therefore, individuals should discontinue use of any wipes that do not state “sterile” and request replacement with sterile wipes from their clotting factor distributor. 

Nurses should also check their supply of alcohol wipes to ensure that they are only using sterile wipes. This is particularly important for patients with indwelling venous access devices (catheters or ports) and for patients with compromised immune systems, but should be standard of care for all patients. 

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia. (October 26, 2011) 

CHAPTERS: Please distribute this information to your membership.
You must sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. To enroll in the PNS, please call (888) UPDATE-U or go online at www.patientnotificationsystem.org

HANY provides this material for your general information only.    HANY does not engage in the practice of medicine, nor does it advocate or recommend specific medical treatments.  You should consult your physician or local treatment center before pursuing any course of treatment.