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heparin FDA Alerts

The FDA Alert(s) below may be specifically about heparin or relate to a group or class of drugs which include heparin.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for heparin

SCA Pharmaceuticals (SCA) Is Issuing a Voluntary Nationwide Recall of Heparin Sodium Compounded Products Due to Incorrect Preservative (Benzyl Alcohol)

Aug 18, 2020

Audience: Consumer, Health Professional, Pharmacy

August 18, 2020 -- Windsor, CT, SCA Pharmaceuticals (SCA) is voluntarily recalling 10 lots of Heparin Sodium to the hospital/user level. The compounded Heparin Sodium bag contains the undeclared preservative benzyl alcohol. The labelling listed methylparaben and propylparaben as preservatives; however, are not present in the product. SCA identified this labeling issue during the investigation of a low potency test result for Heparin Sodium (NDC 70004-0650-46).

Serious adverse reactions including fatal reactions and “gasping syndrome” are likely to occur in premature neonates and low-birth weight infants in the neonatal intensive care unit who receive benzyl alcohol as a preservative in infusion solutions, in any amount. Additional adverse reactions included gradual nervous system deterioration, seizures, bleeding in the skull, blood abnormalities, skin breakdown, liver and kidney failure, low blood pressure, slower than expected heart rate, and loss of sufficient brain blood flow to maintain consciousness. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. Furthermore, benzyl alcohol present in mother’s serum is likely to cross into human milk and may be orally absorbed by a nursing infant. For this reason, preservative-free heparin sodium injections is recommended when heparin therapy is needed during pregnancy. Benzyl alcohol is contraindicated in pediatric patients as well as pregnant or nursing women. SCA has not received any complaints or reports of adverse events to date related to this recall. However, out of an abundance of caution, SCA is voluntarily recalling the lots listed herein.

Heparin Sodium is used as an anticoagulant and is packaged in 500 mL or 1000 mL intravenous bags. The affected Heparin Sodium lots include the following:

Product Description NDC Number Lot Number Beyond Use Date
Heparin Sodium 10 units/mL in 0.9% Sodium Chloride 500 mL Bag (5,000 units/500 mL) 70004-0650-44 1220019289 8/21/2020
Heparin Sodium 5 units/mL in 0.9% Sodium Chloride 500 mL Bag (2,500 units/500 mL) 70004-0655-44 1220019269 8/21/2020
1220019278 8/21/2020
1220019386 8/25/2020
Heparin Sodium 10 units/mL in 0.9% Sodium Chloride 1,000 mL Bag (10,000 units/1,000 mL) 70004-0652-46 1220019457 8/24/2020
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000mL Bag (5 units/mL) 70004-0650-46 1220019243 8/20/2020
1220019439 8/24/2020
1220019279 8/24/2020
1220019392 8/24/2020
1220019488 8/26/2020

The compounded Heparin Sodium can be identified by checking the product name, concentration and lot number on the compounded bag. The compounded Heparin Sodium bags were distributed nationwide to hospitals.

SCA is notifying its customers by certified mail and is arranging for return of all recalled products. Hospitals that have compounded Heparin Sodium bags which are being recalled should stop using the product and return the product to SCA.

Consumers with questions regarding this recall can contact SCA by phone at 877-550-5059 or e-mail customerservice@scapharma.com between the hours of 7:00 am and 7:00 pm (Central Standard Time), Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall - Particulate Matter

Sep 12, 2014

Audience: Pharmacy, Risk Manager

ISSUE: Hospira, Inc. announced a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. This action is due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair, sealed between the tube and the film at the round seal of the unused Administrative Port on the non-print side of the container.

Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Capillaries which may be as small as the size of a red blood cell, approximately seven microns in diameter, may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.

BACKGROUND: The affected lot was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals and pharmacies.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution and quarantine the product immediately. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-855-201-4337 between the hours of 8am to 5pm ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[09/11/2014 - Press Release - Hospira, Inc]

Heparin: Drug Safety Communication - Important change to heparin container labels to clearly state the total drug strength

Dec 6, 2012

Audience: Health Professionals, Patients, Home Care

ISSUE: FDA is notifying health care professionals, caregivers, and patients about a change to the container and carton labels for heparin products.

This label change will require manufacturers of Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP to clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 milliliter (mL). These modifications will eliminate the need for health care professionals to calculate the total amount of heparin medication in a product containing more than 1 mL, thereby reducing the risk of miscalculations that may result in medication errors.

BACKGROUND: Heparin is used to prevent blood clots from forming in people who have certain medical conditions or who are undergoing certain medical procedures that may increase the chance that clots will form, or to stop the growth of clots that have already formed in the blood vessels and to prevent blood clots from forming in catheters that are left in veins over a period of time.

RECOMMENDATION: Health care professionals, caregivers, and patients should be aware that that there will be a transition period before and after the official implementation date on May 1, 2013, during which both the current heparin container labels and the revised heparin container labels will be available in the marketplace. To minimize the potential for medication errors, users should consider separating the supplies of “current” and “revised” labeled heparin, and use all of the supplies of the “current” heparin before using products with the “revised” container label.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[12/06/12 - Drug Safety Communication - FDA]

Heparin Sodium (B. Braun): Recall - Trace Contaminant

Oct 29, 2010

Audience: Pharmacy, Risk Managers

ISSUE: B. Braun Medical Inc. and FDA notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.

BACKGROUND: Heparin is a blood thinner used to treat and prevent blood clots.

RECOMMENDATION: Customers who have product from the recalled product lots in their possession should discontinue use immediately. Product lot numbers, expiration dates, and recall instructions are listed in the Press Release.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[10/27/2010 - Press Release - B. Braun Medical Inc.]

    

Heparin: Change in Reference Standard

Apr 7, 2010

Audience: Pharmacists, physicians, hospital risk managers and consumers

[UPDATE 04/07/2010] Laboratory studies performed at the request of the FDA have shown that Heparin Sodium, USP made under the new United States Pharmacopeia (USP) Monograph ("new heparin") has approximately 10% less blood-thinning (anticoagulant) activity compared to heparin prepared using the previous ("old") USP Monograph.

The results of these studies reinforce FDA's previous recommendation for healthcare professionals to exercise clinical judgment in determining the dose of heparin for a patient and consider the clinical circumstances where the potency decrease may require dosage adjustments and more frequent monitoring.

[Posted 10/01/2009] FDA notified healthcare professionals and patients of a change to heparin, effective October 1, 2009, which will include a new reference standard and test method used to determine the potency of the drug and able to detect impurities that may be present in heparin. The change, which will also harmonize the USP unit dose with the WHO International Standard unit dose, will result in approximately a 10% reduction in the potency of the heparin marketed in the United States.

This may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important. Healthcare providers should be aware of the decrease in heparin potency as they monitor the anticoagulant effect of the drug; more heparin may be required to achieve and maintain the desired level of anticoagulation in some patients.

There will be simultaneous availability of heparin manufactured to meet the "old" and "new" USP monograph, with potential differences in potency. Products using the new "USP unit" potency definition are anticipated to be available on or after October 8. FDA is working with the manufacturers of heparin to ensure that an appropriate identifier is placed on heparin made under the new USP monograph. Most manufacturers will place an "N" next to the lot number. FDA is also working with the heparin manufacturers to study the impact of this variation in potency and will make the results available when the studies have concluded.

[04/07/2010 - Drug Safety Communication - FDA]

[10/01/2009 - Public Health Alert - FDA]

[10/01/2009 - Information for Consumers - FDA]

    

Heparin: Change in Reference Standard

Oct 1, 2009

Audience: Pharmacists, physicians, hospital risk managers and consumers

FDA notified healthcare professionals and patients of a change to heparin, effective October 1, 2009, which will include a new reference standard and test method used to determine the potency of the drug and able to detect impurities that may be present in heparin. The change, which will also harmonize the USP unit dose with the WHO International Standard unit dose, will result in approximately a 10% reduction in the potency of the heparin marketed in the United States.

This may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important. Healthcare providers should be aware of the decrease in heparin potency as they monitor the anticoagulant effect of the drug; more heparin may be required to achieve and maintain the desired level of anticoagulation in some patients.

There will be simultaneous availability of heparin manufactured to meet the "old" and "new" USP monograph, with potential differences in potency. Products using the new "USP unit" potency definition are anticipated to be available on or after October 8. FDA is working with the manufacturers of heparin to ensure that an appropriate identifier is placed on heparin made under the new USP monograph. Most manufacturers will place an "N" next to the lot number. FDA is also working with the heparin manufacturers to study the impact of this variation in potency and will make the results available when the studies have concluded.

[10/01/2009 - Public Health Alert - FDA]

[10/01/2009 - Information for Consumers - FDA]

    

Heparin Sodium Injection

May 9, 2008

Audience: Surgeons, dialysis center staff, hospital risk managers, and other healthcare professionals

[UPDATE 05/15/2008] Atrium Medical Corporation announced that it is initiating a voluntary and precautionary recall of selected lots of Hydraglide Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS).

[UPDATE 05/15/2008] Medtronic Inc., initiated a voluntary recall of selected products featuring the Carmeda BioActive surface. The recalled products are used during cardiopulmonary bypass heart surgeries. Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). It is unclear if exposure to Carmeda-coated medical devices, made with small amount of heparin, could cause adverse events similar to those observed with injectable heparin formulations. Patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time.

Medtronic is also advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. The amount of heparin on the product is significantly lower than that contained on the Carmeda product. Based on current data, the benefit of using the affected products outweighs any potential risk to patients. The maximum possible patient exposure to heparin from Trillium is extremely low; therefore, customers can continue to use the affected Trillium products until a replacement is available.

[UPDATE 05/09/2008] FDA requested that health professionals and facilities review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all recalled heparin products have been removed and are no longer available for patient use. In addition, FDA informed health professionals about other types of medical devices that contain, or are coated with, heparin.

[UPDATE 04/29/2008] Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products.

[UPDATE 02/28/2008] Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions.

[Posted 02/11/2008] FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.

[May 12, 2008 - Press Release - Atrium]
[May 07, 2008 - Press Release - Medtronic]
[April 25, 2008 - Information on Heparin Sodium Injection - FDA/CDER]
[April 25, 2008 - Update to Healthcare Facilities and Healthcare Professionals - FDA/CDRH]
[March 07, 2008 - Updated Questions and Answers - FDA]
[February 28, 2008 - Public Health Update - FDA]
[February 28, 2008 - Press Release - Baxter]
[February 11, 2008 - Questions and Answers - FDA]
[February 11, 2008 - News Release - FDA]

Heparin Sodium Injection

Apr 29, 2008

Audience: Surgeons, dialysis center staff, hospital risk managers, and other healthcare professionals

[UPDATE 04/29/2008] Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products.

[UPDATE 02/28/2008] Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions.

[Posted 02/11/2008] FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.

[April 25, 2008 - Information on Heparin Sodium Injection - FDA/CDER]
[April 25, 2008 - Update to Healthcare Facilities and Healthcare Professionals - FDA/CDRH]
[March 07, 2008 - Updated Questions and Answers - FDA]
[February 28, 2008 - Public Health Update - FDA]
[February 28, 2008 - Press Release - Baxter]
[February 11, 2008 - Public Health Advisory - FDA] UPDATED 02/28/2008
[February 11, 2008 - Questions and Answers - FDA]
[February 11, 2008 - News Release - FDA]

Heparin Sodium USP Pre-Filled Syringes

Apr 2, 2008

Audience: Surgeons, hospital risk managers, pharmacists, other healthcare professionals

[Posted 04/02/2008] Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. See the manufacturer's press release for the list of specific lots of the product affected by the recall. Use of the recalled product should be discontinued immediately. Patients should contact their physician if they experience any problems associated with the use of the product.

[March 28, 2008 - Press Release - Covidien]

B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution

Mar 21, 2008

Audience: Surgeons, dialysis center staff, hospital risk managers, other healthcare professionals

[Posted 03/21/2008] B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant.

[March 21, 2008 - Press Release - B. Braun Medical]

Heparin Sodium Injection (Baxter)

Feb 28, 2008

Audience: Surgeons, dialysis center staff, hospital risk managers, and other healthcare professionals

[UPDATE 02/28/2008] Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions.

[Posted 02/11/2008] FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.

Heparin Sodium Injection (Baxter)

Feb 11, 2008

Audience: Surgeons, dialysis center staff, hospital risk managers, and other healthcare professionals

[Posted 02/11/2008] FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.

]

Heparin Sodium Injection 1000 units/mL 1OmL and 30 mL Vials

Jan 19, 2008

Audience: Pharmacists, hospital risk managers, other healthcare professionals

[Posted 01/18/2008] Baxter Healthcare and FDA notified healthcare professionals of a voluntary recall of certain lots of Heparin as a precaution due to an increase in reports of adverse patient reactions associated with these lots. Baxter is in the process of an in-depth investigation to determine the root cause of the reported reactions.

Reported adverse events include abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. There have been no reports involving fatality. See the recall notice for a list of affected lots.

[January 17, 2008 - Recall Notice - Baxter Healthcare]

Heparin and Normal Saline Pre-Filled Syringe Flushes

Jan 18, 2008

Audience: Pharmacists, hospital risk managers, other healthcare professionals, patients

[Posted 01/18/2008] AM2 PAT, Inc., notified healthcare professionals and patients of a nationwide recall of all lots of both Heparin and Normal Saline pre-filled flushes. These products are distributed under two brand names, Sierra Pre-Filled Inc and B. Braun. The products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was contaminated with Sierratia marcescens which has resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

User facilities and consumers should stop using the product immediately, quarantine remaining inventory, and return the product to their respective distributor. For a complete list of the recalled products, see the Recall Notice.

[January 18, 2008 - Recall Notice - AM2 PAT, Inc.]

Heparin Lock Flush Solution (Pre-Filled 5 ml in 12 ml Syringes)

Dec 21, 2007

Audience: Hospital and nursing home administrators, hospital risk managers, pharmacists, other healthcare professionals, consumers

[Posted 12/21/2007] AM2 PAT, Inc., and FDA informed healthcare professionals and consumers of a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution (5 ml in 12 mL Syringes), Lot # 070926H. The heparin IV flush syringes were found to be contaminated with Serratia marcescens, which have resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. Consumers and user facilities should immediately stop using the product, quarantine it and return the affected product to the distributor.

[December 20, 2007 - Press Release - AM2 PAT, Inc]

Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL Medication Errors

Feb 7, 2007

Audience: Pharmacists, neonatology/pediatric healthcare professionals

[Posted 02/07/2007] Baxter and FDA notified healthcare professionals of the potential for life threatening medication errors involving two Heparin products, Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL. Baxter is aware of fatal medication errors that have occurred when two Heparin products with shades of blue labeling were mistaken for each other. Three infant deaths resulted when the higher dosage Heparin Sodium Injection 10,000 units/mL was inadvertently administered instead of the lower dosage of HEP-LOCK U/P 10 units/mL. The currently marketed 1 mL vials of both Heparin products use blue as the prominent background color on their labels.

[February 06, 2007 – Letter– Baxter]

Heparin Sodium Injection - Dec 8, 2006

Dec 8, 2006

Audience: Vascular surgeons, ER personnel, pharmacists, and other healthcare professionals

[Posted 12/08/2006] FDA notified healthcare professionals of revisions to the WARNINGS section of the prescribing information for Heparin to inform clinicians of the possibility of delayed onset of heparin-induced thrombocytopenia (HIT), a serious antibody-mediated reaction resulting from irreversible aggregation of platelets. HIT may progress to the development of venous and arterial thromboses, a condition referred to as heparin-induced thrombocytopenia and thrombosis (HITT). Thrombotic events may be the initial presentation for HITT which can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.

Heparin Sodium Injection, USP

May 1, 2002

Audience: Healthcare professionals

Wyeth Pharmaceuticals and ESI Lederle are voluntarily recalling ALL lots of Heparin Sodium Injection, USP (Porcine Derived) 1,000 units per mL, 1 mL DOSETTE ® Vial, 10 mL and 30 mL Multiple Dose Vials due to the presence of clear crystals containing an antioxidant compound from the vial rubber closures.

[May 1, 2002 Letter to Health Care Providers - Wyeth/ESI Lederle]
[May 1, 2002 Letter to Customers/Distributors - Wyeth/ESI Lederle]
[May 1, 2002 Drug Shortage Information - FDA]

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