Medical Recalls

 

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

Lot Number

Size

Packaging

Expiration Date

0944-2700-06

LE12LG70AC

20g

vial

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 #414  WARNING ABOUT USE OF NON-STERILE ALCOHOL WIPES
October 26, 2011

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.

 

Medical Advisory #413:Baxter Voluntarily Recalls One Lot of Recombinate
July 28, 2011

Baxter BioScience has announced that it is voluntarily recalling one lot of Recombinate Antihemophilic Factor (Recombinant). Baxter states that this recall is being taken as a precautionary measure after a retrospective review of its manufacturing process revealed a breach in aseptic processing.  This lot did meet all in-process and final container specifications, which include sterility and pyrogenicity. There have been no adverse events reported regarding use of this lot of Recombinate to date. This action is being taken with the knowledge of the U.S. Food and Drug Administration (FDA).

Recalled Lot:

Lot Number - TRA09834AB
AHF IU/vial - 1060
Expiration Date 1-28-2012

If you have any of this product in your possession, please contact Baxter Customer Service at: 1-800-423-2090 for instructions on how to return the product and obtain a replacement.

 

 

 

 

 

URGENT: Voluntary Market Withdrawal Initiated by Octapharma USA Inc.

September 28, 2010

Event Id: 144

Event Date: 09-24-2010

Therapy: Octagam®

NDC NumberLot NumberSizePackagingExpiration Date
67467 0843 01 All Lots 20 mlvial 09-24-2010
67467 0843 02 All Lots 50 mlvial 09-24-2010
67467 0843 03 All Lots 100 mlvial 09-24-2010
67467 0843 04 All Lots 200 mlvial 09-24-2010
67467 0843 05 All Lots 500 mlvial 09-24-2010
68209 0843 01 All Lots 20 mlvial 09-24-2010
68209 0843 02 All Lots 50 mlvial 09-24-2010
68209 0843 03 All Lots 100 mlvial 09-24-2010
68209 0843 04 All Lots 200 mlvial 09-24-2010

Reason

This withdrawal is being conducted as a precautionary measure. An earlier withdrawal on August 20, 2010 was performed as a result of an increased number of reported thromboembolic events, some of which were serious. A total of 31 lots were voluntarily withdrawn at that time. While Octapharma has not received any reports of thromboembolic events since this voluntary market withdrawal was performed, Octapharma has suspended distribution of octagam® pending the discovery of the root cause of the previously reported thromboembolic events and corrective actions taken.

Action

  1. Do not take this product. Return any and all product to the point of purchase or to your healthcare provider.
  2. Contact your physician if you have medical questions.

Other Information

If you need assistance, please call your physician or Octapharma Medical Affairs at 201 604 1130

CSL Behring Initiates Field Correction of Component Packs Packaged with Specific Lots of Mononine

Friday, November 21, 2008

CSL Behring L.L.C. is initiating a field correction of component packs packaged with five specific lots of Mononine�. The packs do not have a complete seal between the soft blister pack and the package cover.

This action is being taken with the knowledge of the U.S. Food and Drug Administration (FDA). This is not a recall or withdrawal of the product itself�Mononine� therapy has not been compromised in any way. The product and its diluent are safe to use.

CSL is requesting that these lots of the component packs be immediately discontinued and returned to the company, where they will be exchanged for a completely sealed version. The five affected lots are listed in the accompanying letter from CSL Behring. Note: to qualify for the exchange, the following must correspond: Mononine� Lot Number, NDC Number and Component Pack Lot Number.

The following is a list of the five lots that should be exchanged, along with their respective expiration dates:

Table of Mononine Lot Recalls

If you have questions, please contact CSL Customer Support: 1.800.683.1288.

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

CHAPTERS: Please distribute this information to your membership.

Patient Notification System (PNS)

Please sign up for the Patient Notification System (PNS) for direct notifications about the latest recall or withdrawal of recombinant and plasma products. The system is free, confidential and time sensitive. It is administered by an independent third-party organization.

To enroll in PNS, please visit its Web site: http://www.patientnotificationsystem.org

Medefill Inc. Recalls Lots of Heparin IV Flush Syringes

3/24/08

List of recalled lots

Letter from Medefil regarding recalled products 

Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products

Contact:
Erin Gardiner, (847) 948-4210
Deborah Spak, (847) 948-2349

FOR IMMEDIATE RELEASE -- DEERFIELD, Ill., February 28, 2008 � Baxter International Inc. announced today that the company is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.

The company initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production earlier this month.

Given the widespread use of this blood thinner and the impact a product shortage would have on operating rooms, dialysis centers and other critical care areas, the FDA and Baxter concluded that removing additional lots and doses of Baxter's heparin from the market earlier would have created more risk to patients requiring heparin therapy than the increased potential for experiencing an adverse reaction. Accordingly, the FDA and Baxter decided not to recall all Baxter heparin vial products at that time. The FDA has now concluded that there is sufficient capacity on the part of other suppliers that Baxter's recall will not jeopardize access to this drug, and has told Baxter that the company can now proceed with recalling its remaining heparin sodium injection and heparin flush products.

Although the vast majority of the reports of adverse reactions have been associated with the multi-dose products, Baxter is taking the precautionary step of recalling all remaining heparin sodium injection and heparin flush products that are currently on the market. In addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials, Baxter's recall will now include the remaining lots of those products and heparin sodium injection 5000 units/mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free.

This recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.

"We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs," said Peter J. Arduini, president of Baxter's Medication Delivery business. "The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue."

Nearly all reported adverse reactions have occurred in three specific areas of product use � renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.

Customers have been instructed to discontinue use and segregate the recalled product from the rest of their inventory. Customers should then contact Baxter to arrange for return and replacement product. Customers with recalled product purchased indirectly should contact their wholesaler or distributor for return and replacement product. Customers with questions may contact the Center for One Baxter at 1-800-4-BAXTER (1-800-422-9837). Representatives will be available twenty-four hours a day, seven days a week.

Patient Notification System (PNS)

PNS is a product recall information system to inform people when a blood product is being withdrawn or recalled. PNS is a NO COST, CONFIDENTIAL, 24 HOUR COMMUNICATION system providing information on plasma-derived and recombinant products.

PNS is administered by National Notification Center (NNC) a third-party administrator. The NNC is restricted from revealing identities of anyone registered. Information submitted through the web interface is encrypted and confidentiality is the first and foremost priority of PNS.

All PNS participants can select how they wish to be notified (by phone, fax or e-mail). All PNS participants receive a follow-up first-class letter to ensure the recipt of information.

CALL 1-888-873-2838 or (800-UPDATE-U) to register or Register online at Patient Notification System "The Patient Notification System (PNS) is a model for cooperation and communication between industry and consumers." Dr. John Boyle Plasma Users Coalition.

Other resources for tracking product recalls:

U.S. Food and Drug Administration Please refer to the site by clicking on Food & Drug Administration NHF MASAC Recommendation # 73 (NHF Medical Advisory # 302) If you are interested in MASAC recommendations regarding blood safety policies adopted November 2, 1997 Please refer to the NHF site by clicking on NHF MASAC Recommendation

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

Lot Number

Size

Packaging

Expiration Date

0944-2700-06

LE12LG70AC

20g

vial

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.


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