Update On Recalled Heparin By FDA

Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recommendations on this continuing issue. Heparin is an anticoagulant commonly used subcutaneously and intravenously in patients undergoing kidney dialysis, certain types of cardiac surgery and other procedures. It is also used in lock flush solutions to maintain the patency of IV catheters, and as a coating or ingredient in certain medical devices and diagnostic products. Towards the end of 2007, FDA started receiving an increasing number of reports of adverse events associated with injectable heparin products, especially when the heparin was administered as a bolus dose. Many of these events were consistent with either an anaphylactic-type reaction or acute hypotension. A small number of similar events have also been reported for heparin flush solutions. FDA has identified a contaminant in the heparin, an oversulfated chondroitin sulfate, that may have led to the adverse events. This contaminant mimics heparin activity so closely that routine testing did not uncover it. Special test methods are needed to detect this contaminant, and the major U.S. heparin manufacturers and suppliers have agreed to perform these tests to screen all heparin active ingredient that they receive. FDA has also asked medical device companies to identify any product they market that contains heparin or uses heparin in processing. A number of companies have recalled heparin or products containing heparin. They did this based either on reports of adverse events or as a precaution after the special testing revealed that the company had been supplied with contaminated lots of heparin. FDA is asking healthcare professionals and facilities to take the following steps: • Report adverse reactions associated with any drug or device that contains heparin. FDA is continuing to actively monitor this situation and it is essential that new events are reported as soon as possible. FDA is focusing on events involving injectable heparin, heparin lock flush solutions or medical devices that contain heparin. That could include certain blood collection tubes, intravascular catheters, vascular stents and grafts, and other devices used during cardiac procedures, such as oxygenators, pumps, filters and blood reservoirs. • Pay attention to recalls of heparin or heparin-containing products, including those by Baxter Healthcare, American Health Packaging, B. Braun, Covidien, Medtronic and Atrium Medical. • Check all drug and device storage areas, including emergency kits, crash carts, dialysis units and automated drug storage cabinets, to make sure that all recalled heparin products have been removed and are no longer available for use. The investigation of contaminated heparin is still underway. The links (see "Additional Information" below) will be updated with the latest information as it becomes available. Additional Information: FDA. Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products. http://www.fda.gov/cder/drug/infopage/heparin/default.htm#healthcare FDA. Information on Heparin Sodium Injection. April 25, 2008. http://www.fda.gov/cder/drug/infopage/heparin/default.htm FDA MedWatch Safety Alert. Heparin Sodium Injection. May 15, 2008. http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2

Tags: FDA News, Heparin, HEPARIN RECALL

Multiple-dose Vial Heparin From Baxter Healthcare Corporation Linked to Severe Allergic Reactions

FOR IMMEDIATE RELEASE February 11, 2008

Media Inquiries: Karen Riley, 301-827-6244 Consumer Inquiries: 888-INFO-FDA

Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions
FDA advises health care practitioners to switch suppliers and limit use of drug until problem identified

The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.

Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people have died after receiving heparin, although the relationship to the drug is unclear.

Heparin sodium is derived from pig intestines and has been marketed in the United States since the 1930s. Millions of patients benefit from the intravenous administration of this drug every year to avoid potentially life-threatening blood clots in the veins, arteries, and lungs.

"FDA concurs with Baxter's decision to halt manufacture of heparin sodium in multiple-dose vials," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research. "FDA is vigorously investigating to determine the root cause of these serious reactions associated with the use of heparin made by Baxter. In the meantime, patients and health care professionals who cannot obtain alternative sources of heparin should use caution in administering any Baxter multiple-dose vials that remain."

Heparin is commonly used before certain types of surgery, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis. In some situations, heparin treatment is initiated using a high bolus dose given directly into the bloodstream (intravenously) over a short period of time, usually less than one hour. The reported adverse events occurred in patients who were given heparin in this form of administration. There are many other uses of heparin involving lower doses or administration over a longer period of time; adverse events have not been seen with those uses.

About 350 adverse events associated with the Baxter product have been reported since the end of last year compared to less than 100 reports in 2007. Most of the events have taken place at hemodialysis centers, almost exclusively involving patients receiving a bolus dose – which is a high dose administered over a short time. While most of the reports involve multiple-dose vials, several cases include patients who received a bolus dose after their health care professional combined heparin from single-dose vials.

The Missouri Department of Health and Senior Services first notified the Centers for Disease Control and Prevention (CDC) in January of several severe allergic-type reactions to heparin that occurred at a single pediatric hospital beginning in November. The CDC in turn alerted FDA and Baxter, prompting the company's voluntary recall of nine lots of heparin on Jan. 17.

Since then, FDA has learned of adverse events that extend beyond the recalled lots and involve patients receiving heparin for other purposes besides hemodialysis. Recent cases have included patients undergoing cardiac surgery and a specialized blood cell treatment known as photopheresis.

Over one million multiple-dose vials of heparin are sold per month in the United States; half of the vials are manufactured by Baxter of Deerfield, Ill. FDA is currently investigating whether similar events have been seen with other heparin manufacturers.

Physicians, dialysis center staff and health care providers are advised to use an alternate source of heparin or another blood-thinning drug when possible. When only Baxter product is available:

• Administer the heparin as an infusion (not a bolus) whenever possible.
• Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired clinical effect.
• Closely monitor the patient for adverse events, particularly hypotension and signs and symptoms of hypersensitivity and ensure that resuscitation equipment is available.
• Consider pretreatment with corticosteroids (cortisone type medicines) or antihistamines (drugs that relieve the symptoms of allergic reactions) although it is not known if such pretreatment is effective.

Any allergic-type reaction to heparin infusion should be reported to FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, M.D. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

tag: FDA Recall, Missouri Department of Health, heparin, CDC, Baxter, hemodialysis, photopheresis, Baxter of Deerfield, hypersensitivity, corticosteroids, MedWatch, Multiple-dose Vial Heparin, Baxter Healthcare Corporation

Update And Request On Heparin Sodium Injection (Baxter)

[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.

Tags: FDA Recall, Drug recall, Heparin Recall, Baxter Recall

AM2 PAT, Inc., issues nationwide recall of all pre-filled syringe flushes

FDA today released a public warning and nationwide recall of contaminated syringes by AM2 PAT, Inc. These are pre-filled flush syringes with heparin and saline that have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death. This is an update to an earlier recall of the same products.

FOR IMMEDIATE RELEASE January 25, 2008

Media Inquiries: Peper Long, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Warns Public of Contaminated Syringes
AM2 PAT, Inc., issues nationwide recall of all pre-filled syringe flushes

The U.S. Food and Drug Administration (FDA) today announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.

Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA.

The recall affects all lots of these products. The FDA received information that Heparin Lock Flush syringes from Lot 070926H and Normal Saline IV syringes from Lot 070917A have been found to be contaminated with Serratia marcescens, and have resulted in patient infections. The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes.

Traditionally, Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections.

The company voluntarily recalled these products on Jan. 18 after confirming bacterial contamination in some user samples.

Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10 a.m. to 5 p.m. EST.

Any adverse reactions experienced with the use of the products, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, M.D. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, N.C.

PRODUCT DESCRIPTION:
Heparin Lock Flush Solution USP, All Strengths and Sizes
Normal Saline IV Flush Solution USP, All Strengths and Sizes

Sierra Pre-Filled Inc. Products:

NDC#	CATALOG #	Product
64054-1003-02	1003-02	Heparin Lock Flush 100units/mL 5mL
64054-1003-01	1003-01	Heparin Lock Flush 100units/mL 3mL
64054-3005-02	3005-02	Heparin Lock Flush 10units/mL 5mL
64054-3003-02	3003-02	Heparin Lock Flush 10units/mL 3mL
64054-3003-06	3003-06	Heparin Lock Flush 10units/mL 3mL (6mL syringe)
64054-3005-06	3005-06	Heparin Lock Flush 10units/mL 5mL (6mL syringe)
64054-0910-2	0910-12	Normal Saline IV Flush 10mL
64054-0905-2	0905-12	Normal Saline IV Flush 5mL
64054-0903-2	0903-12	Normal Saline IV Flush 3mL

B. Braun Products:

NDC#	CATALOG #	Product
64054-3005-02	513610	Heparin Lock Flush 10units/mL 5mL
64054-1003-01	513611	Heparin Lock Flush 100units/mL 3mL
64054-1003-02	513612	Heparin Lock Flush 100units/mL 5mL
64054-0903-2	513584	Normal Saline IV Flush 3mL
64054-0905-2	513586	Normal Saline IV Flush 5mL
64054-0910-2	513587	Normal Saline IV Flush 10mL

#

tag: FDA Recall, AM2 PAT recall, heparin and saline pre-filled flush syringe, Sierra Pre-filled, pre-filled Heparin Lock, Normal Saline IV Flush, MedWatch,

AM2 PAT, Inc. Issues Nationwide Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes

NATIONWIDE URGENT DEVICE RECALL
RECALL EXPANSION 2nd Notice

FOR IMMEDIATE RELEASE DATE 01/18/08

AM2PAT, INC. (doing business as Sierra Pre-Filled Inc)
455 W. DEPOT STREET
ANGIER, NC 27501
919-552-9689

AM2 PAT, Inc. Issues Nationwide Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes

AM2 PAT, Inc., Angier, North Carolina, is initiating a Nationwide recall of all lots of both Heparin and Saline pre-filled flushes manufactured by AM2 PAT. These products are distributed under two brand names, Sierra Pre-Filled Inc. and B. Braun. These products are sold in 3ml, 5ml sizes for Heparin and 3ml, 5ml and 10ml sizes for Normal Saline. Both products are sold as pre-filled syringes.

One lot under recall of this product 1003-02, Lot 070926H, Heparin IV flush syringes has been found to be contaminated with Serratia marcescens, which has resulted in patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product.

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 who have any of these recalled pre-filled syringes, Heparin or Saline Lock Flush Solution USP, should stop using the product immediately. These products should be immediately quarantined in your inventory and returned to your distributor immediately.

The following information for this recall includes:

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, North Carolina

PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, All Strengths and Sizes

Saline Lock Flush Solution USP, All Strengths and Sizes

LOT #	NDC #	CATALOG #	Product Brand Name
All	64054-1003-02	1003-02	Heparin Lock Flush 100units/ml 5ml
	64054-1003-01	1003-01	Heparin Lock Flush 100units/ml 3ml
	64054-3005-02	3005-02	Heparin Lock Flush 10units/ml 5ml
	64054-3003-02	3003-02	Heparin Lock Flush 10units/ml 3ml
	64054-3003-06	3003-06	Heparin Lock Flush 10units/mL 3ml (6ml syringe)
	64054-3005-06	3005-06	Heparin Lock Flush 10units/mL 5ml (6ml syringe)
	64054-0910-2	0910-12	Normal Saline Flush 10ml
	64054-0905-2	0905-12	Normal Saline Flush 5ml
	64054-0903-2	0903-12	Normal Saline Flush 3ml

The firm voluntarily recalled these products after confirming bacterial contamination in some end user samples of product code 1003-02, Lot 070926H.

These products have been distributed nationwide.

It appears from an ongoing Food and Drug Administration (FDA) inspection of AM2 PAT, Inc.’s facility that the firm is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.

Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10am-5pm Eastern Standard Time.

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

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

tag: Sierra Pre-Filled Inc recall, FDA, FDA Medwatch, CDC, AM2PAT recall, Pre-Filled Heparin Recall, pre-filled Saline Flushes Recall, Heparin IV flush syringe Recall, Serratia marcescens,

Heparin Trouble In Germany Too!

New York Times is reporting that Germany has recalled and issued warnings on heparin that were made with ingredients from China.

In the United States, there are 19 deaths related heparin and the US manufacturer Baxter took it's sweet time recalling heparin, since December 2007. We covered it since initial FDA warning and heparin recall in December 2007 to the latest heparin news that there were deaths associated with heparin. But news continue to fill the media waves.

FRANKFURT — The German authorities said Friday that they had asked all German producers of the blood thinner heparin to check whether their ingredients came from China, after allergic reactions to the drug there were linked to two Chinese suppliers.

In cases where China did supply the raw ingredient, manufacturers were asked to test for any irregularities. The German authorities recalled the suspect heparin on Wednesday after receiving reports of allergic reactions in about 80 patients.

The suspect heparin in the United States was made by Baxter International, with ingredients from a Chinese company called Changzhou SPL. The discovery that the ingredients for the German-made heparin came from two different Chinese plants has led investigators to suspect that the problem may lie farther back in the supply chain.

tag: FDA Recall, drug recall, Changzhou SPL, heparin, HEP-LOCK products, Baxter International recall,

Baxter Recalls All Heparin Sodium Injection

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. The Baxter lots of Heparin was linked to mix up of factory names in China that prevented proper inspection.

• Public Health Update: Recall of Heparin Sodium for Injection (2/28/2008)
• FDA-483 on Heparin (2/28/08)
• Public Health Advisory (2/11/2008)
• Question and Answers (2/11/2008)
• FDA News (2/11/2008)
• Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products (2/28/08)
• Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials (1/25/2008)
• Transcript of FDA Press Conference on Adverse Events Associated with Baxter Healthcare Corporation’s Multiple-Dose Vials of Injectable Heparin (2/18/2008 and 2/11/2008)

tag: FDA Recall, Missouri Department of Health, heparin, CDC, Baxter, hemodialysis, photopheresis, Baxter of Deerfield, hypersensitivity, corticosteroids, MedWatch, Multiple-dose Vial Heparin, Baxter Healthcare Corporation

Report Links Baxter Heparin to More Deaths

NEW YORK (Associated Press) - A day after Baxter International Inc. recalled nearly all remaining batches of its blood thinner heparin, a report Friday linked the product to additional patient deaths.

Late Thursday, Baxter said it will recall all remaining lots of heparin single- and multi-dose injections and HEP-LOCK products. The company recalled nine production lots of heparin multi-dose injection in January after the drug was linked to four deaths and hundreds of allergic reactions.

On Friday, the New York Times reported that the Food and Drug Administration had discovered possible links to 17 other deaths. The paper added that the agency is focusing on a Chinese plant that supplies the active ingredient in heparin, which is made from mucous membranes extracted from pig intestines.

In a letter posted to the FDA Web site Thursday, the FDA discussed problems in the manufacturing process. It said some lots of heparin sold in the U.S. "included material from an unacceptable workshop vendor," among other issues.

While the FDA investigation is not complete, Goldman Sachs analyst Lawrence Keusch said there was reason to believe the problem was linked to the Chinese plant, Changzhou SPL.

"Baxter and the FDA have ruled out any issues at the company's Cherry Hill, New Jersey, finishing facility," he said. He added that the only form of Baxter's heparin left on the market is a premixed IV solution, which is not sourced from China.

Keusch said the expanded recall is not a surprise, and won't have much impact on Baxter.

"From a financial perspective, heparin sales were roughly $30 million in 2007, and with a gross margin of 20 percent are not material to earnings," he said.

He added the recall is unlikely to affect other Baxter product, because only a few of its minor products are processed in China, and none are made at the facility cited by the FDA.
tag: FDA Recall, drug recall, Changzhou SPL, heparin, HEP-LOCK products, Baxter International recall,

B. Braun Medical Inc. Recalls All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flush Syringes

B. Braun's Supplier Prompts Voluntary Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flush Syringes
AM2PAT Inc. manufactures these pre-filled syringes under both its private label, Sierra Pre-Filled Inc., as well as under the B. Braun Medical Inc. label

Contact:
Stephanie Euler, 908-276-4344 ext. 213
Susan Denby, 610-997-4856

FOR IMMEDIATE RELEASE -- January 18, 2008 -- B. Braun Medical Inc. was recently notified by its contract manufacturer, AM2PAT Inc., of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes.

Catalog #	Lot #	Description
513584	All	Normal Saline 3mL in 12 mL Syringe
513586	All	Normal Saline 5mL in 12 mL Syringe
513587	All	Normal Saline 10mL in 12 mL Syringe
513610	All	10 units/mL Heparin, 5mL in 12 mL Syringe
513611	All	100 units/mL Heparin, 3mL in 12 mL Syringe
513612	All	100 units/mL Heparin, 5mL in 12 mL Syringe

Customers that have the recalled product in their possession should discontinue use immediately. If patients report any problems that may be related to usage of this product a physician should be contacted. Customers may contact the B. Braun Medical Inc. Customer Support Department at (800) 227-2862, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.

Based on ongoing FDA inspection of AM2PAT Inc.'s facility, and CDC investigation it has been determined that there is a potential for the sterility of these affected products to be compromised, which may result in potential contamination. AM2PAT previously initiated a recall of one lot of Sierra Pre-Filled Heparin (lot #070926H) that was found to be contaminated with Serratia marcescens, which may lead to patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product in this specific AM2PAT lot. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

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.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

tag: FDA, FDA Medwatch, B. Braun Medical recall, FDA Recall, Pre-Filled Heparin Recall, pre-filled Saline Flushes Recall, Heparin IV flush syringe Recall, Serratia marcescens,

AM2 PAT, Inc. Recalls Pre-Filled Heparin Lock Flush Solution

AM2 PAT, Inc. Issues Nationwide Recall of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes)

Contact:
AM2PAT, INC.
919-552-9689

FOR IMMEDIATE RELEASE --ANGIER, NC -- December 20, 2007 --- AM2 PAT, Inc., Angier, North Carolina, is initiating a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. The heparin IV flush syringes have been found to be contaminated with Serratia marcescens, which have resulted in patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product.

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 who have these recalled pre-filled syringes, Heparin Lock Flush Solution USP, should stop using the product immediately. Please quarantine the affected product in your inventory and return it to your distributor immediately.

The following information for this recall includes:

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, North Carolina

PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, 100 units/ml, 5ml in pre-filled syringes.

LOT# NDC# CATALOG #
070926H 64054-1003-02 1003-02

The firm voluntarily recalled this product after confirming bacterial contamination in some end user samples.

This product was distributed nationwide including the following states: Florida, Texas, Illinois, Colorado, and Pennsylvania.

It appears from an ongoing Food and Drug Administration (FDA) inspection of AM2 PAT, Inc.’s facility that the firm is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.
The firm is continuing to work with FDA and CDC on monitoring this situation and FDA will provide continuing updates.

Consumers with questions may contact the company at 1-919-552-9689 or 847-691-6500 { MONDAY THROUGH FRIDAY 9AM EASTERN TILL 5PM EASTERN}

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Tags: DRUG recall, AM2 PAT recall, Heparin Lock Flush Solution recall, FDA Recall

Another Heparin related Recall, Medtronic, Inc. Recalls Heparin-Coated Products Used During Cardiopulmonary Bypass.

Recallr is reporting another heparin related recall. The company is Medtronic INC and the products are those which featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action is being taken subsequent to the U.S. Food and Drug Administration's April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action.
Recallr: Medtronic, Inc. Recalls Heparin-Coated Products Used During Cardiopulmonary Bypass.
Tags: FDA Recall, heparin recalls, Medtronic Recall, Heparin-Coated Products Recall, Carmeda BioActive surface Recall, blood oxygenators, reservoirs, pumps, cannulae, tubing packs

China Places New Oversight over Heparin Production.

New York Times is reporting about Chinese State Food and Drug Administration taking action on heparin manufacture. Why Now? Why only Heparin? why not food, toys and anything else that is produced in China and exported.
SHANGHAI — China’s top drug safety agency has ordered its local bureaus to increase supervision over the production of heparin, a blood-thinning drug that has been linked to at least 19 deaths and hundreds of allergic reactions in the United States, China’s state-run news agency reported Friday.
Read more at NY Times.
tag: Heparin, Chinese Heparin, Chinese FDA

Another firm, B. Braun Recalls Heparin Solutions (II)

Heparin is being recalled worldwide and now B. Braun Medical Inc is recalling the same. The Scientific Protein Laboratories LLC has supplied the raw heparin to B.Brown as well. The facts about Scientific Protein Laboratories LLC were released a long time ago.
Recallr: B. Braun Recalls Heparin Solutions (II)

tag: heparin recalls, B. Braun Medical Inc Recall, Scientific Protein Laboratories, oversulfated chondroitin sulfate, Changzhou SPL

Chinese Factory Linked to Drug Heparin?

WASHINGTON — A Chinese factory that has not been inspected by the Food and Drug Administration is the source for the active ingredient of a critical blood-thinning drug whose production was suspended this week after 350 patients reported ill effects from it.

At least four people died after being given the drug, heparin.
An F.D.A. spokeswoman, Heidi Robello, said Wednesday that the agency was making plans to inspect the Chinese factory as well as a finishing plant in New Jersey "as soon as possible."

She said that "it was yet to be determined" if the Chinese plant was the source of the problem that led to the spike in reports of problems with the drug's use.

Heparin is made from pig intestines. Ms. Robello said that she did not know whether the pigs used to produce the suspended product, made by Baxter International, came from China.

tag: FDA, heparin, Chinese drug factory

Altered Heparin Source Is Being Traced.

Scientists investigating a mystery contaminant in the blood thinner heparin are closing in on what they believe is a counterfeit substance, most likely made in China from animal cartilage, that was chemically altered to act like the real drug.

The United States Food and Drug Administration declined to confirm that statement and a spokeswoman said the agency would have no comment.

But in interviews, heparin experts in China and the United States — including one researcher involved in the inquiry — said that a chemically altered substance called over-sulfated chondroitin sulfate is probably the contaminant that the F.D.A. says is linked to hundreds of allergic reactions and 19 deaths.

Even so, researchers said they were not certain that the contaminant, constituting between 5 percent and 20 percent of the drug, is what is causing the allergic reactions, nor do they know precisely how or when it was mixed into the active ingredient.

Continue read at NY Times.

tag: Heparin Recall, over-sulfated chondroitin sulfate, chondroitin sulfate,

Recallr: American Health Packaging Recalls Heparin Sodium Vial Products as Part of Broader Baxter Recall

American Health Packaging Announces a Recall of Approximately 1,400 Units of Heparin Sodium Vial Products as Part of Broader Baxter Recall
Units for Pharmacy Automated Equipment Part of Broader Recall
Recallr: American Health Packaging Recalls Heparin Sodium Vial Products as Part of Broader Baxter Recall
tag: Baxter Recall, FDA Recall, American Health Packaging Recall, Heparin Recall, AmerisourceBergen Corporation Recall

Despite Recalls Drug Companies Stand By China.

As we informed today that FDA itself is seeking to establish FDA offices in China, Boston Globe has an article that despite worldwide recalls of Chinese made drugs, more and more drug companies are flocking to China to reduce production costs, and of course larger profits.
Of course when questioned the companies say problems such as the recent heparin related deaths in the USA and the subsequent all heparin recall in USA and Germany, Panama's antifreeze lazed medicine and the tainted leukemia drugs found in China itself are isolated incidents. They say they have the same quality-control standards in China. But I wonder if they are following these standards.
The article mentions the FDA itself thinks that there are many companies that follow the rules while there many who are in the other end of the spectrum. ""While some Chinese [drug] companies are state-of-the art in technology and manufacturing expertise, many are at the opposite end of the spectrum," FDA deputy commissioner Murray Lumpkin told Congress last year."
What ever the reasons, it is hard to believe the damage these drug companies are causing to general populace. So I invite you to read this article by Boston Globe, which tries to look at the issue from many fronts, including Massachusetts's own companies that manufacture drugs in China.
tag: Drug Companies, Drug Manufacture, FDA in China, heparin recall, Chinese made drugs,

Mix Up Of Names Prevented Chinese Heparin Factory Inspection, FDA

Chinese Factory Linked to Drug Heparin?

That we reported last week as well as Baxter recall, the factory has not been inspected by FDA due to mixup of names. FDA has mistakenly assumed that the factory was earlier inspected while it was not. The FDA's explanation, by Joseph Famulare, deputy director of compliance for the FDA's center for drug evaluation and research, comes amid questions about the safety of different types of goods made in China and the adequacy of the FDA's inspection procedures for drugs entering the U.S. from China.
source

tag: FDA, Heparin,

Pfizer's Fragmin (dalteparin sodium) injection, the first anticoagulant (blood thinner) for pediatric patients Approved By FDA

Prior to the approval of Fragmin (dalteparin sodium) injection by Pfizer, there was no drug to treat the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. VTE can include deep vein thrombosis (blood clot in the deep veins of the leg) and pulmonary embolism (blood clot in the lungs), which can lead to death.

Fragmin was initially approved by the FDA in 1994 for adults and is a type of heparin, which works as an anticoagulant. The efficacy of Fragmin in children was based on a single trial with 38 pediatric patients with symptomatic deep vein thrombosis and/or pulmonary embolism. Patients were treated with Fragmin for up to three months, with starting doses by age and weight. At study completion, 21 patients achieved resolution of the qualifying VTE, seven patients showed regression, two patients showed no change, no patients experienced progression of the VTE and one patient experienced recurrence of VTE. 

“Most children who have VTE are fighting a serious underlying primary illness such as cancer or congenital heart disease. Not only are they fighting a serious illness, having a condition like VTE can then lead to significant complications and even death, Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients. Given the unmet need, we granted the Fragmin application priority review and today we are approving it as the first anticoagulant (blood thinner) indicated for pediatric patients. We remain committed to advancing treatments for children with unmet medical needs.” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. 

FDA News Release;

 

FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots

The U.S. Food and Drug Administration today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. VTE can include deep vein thrombosis (blood clot in the deep veins of the leg) and pulmonary embolism (blood clot in the lungs), which can lead to death.

“Most children who have VTE are fighting a serious underlying primary illness such as cancer or congenital heart disease. Not only are they fighting a serious illness, having a condition like VTE can then lead to significant complications and even death,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients. Given the unmet need, we granted the Fragmin application priority review and today we are approving it as the first anticoagulant (blood thinner) indicated for pediatric patients. We remain committed to advancing treatments for children with unmet medical needs.”

VTE usually develops as a secondary complication of underlying clinical conditions such as a venous catheter, cancer, infection, congenital heart disease, and trauma or surgery. Pediatric VTE is associated with an increased risk of in-hospital mortality, recurrent VTE and post-thrombotic syndrome (damage to vein).

Fragmin was initially approved by the FDA in 1994 for adults and is a type of heparin, which works as an anticoagulant. The efficacy of Fragmin in children was based on a single trial with 38 pediatric patientswith symptomatic deep vein thrombosis and/or pulmonary embolism. Patients were treated with Fragmin for up to three months, with starting doses by age and weight. At study completion, 21 patients achieved resolution of the qualifying VTE, seven patients showed regression, two patients showed no change, no patients experienced progression of the VTE and one patient experienced recurrence of VTE.

Common side effects of patients taking Fragmin are bleeding, including hemorrhage (heavy discharge of blood from a blood vessel), thrombocytopenia (low blood platelet count), hematoma (collection of blood) or pain at the injection site and transient elevation of transaminases (elevated level of liver enzymes).

Health care professionals are advised to use caution in conditions with increased risk of hemorrhage and monitor thrombocytopenia of any degree closely. Health care professionals are warned not to use benzyl alcohol preservative multiple-dose formulations in infants as they contain benzyl alcohol and should not be used. Patients are advised to have blood count laboratory tests periodically. Health care professionals are advised to monitor patients closely for bleeding when administering Fragmin to patients who currently take anticoagulants. Patients at risk for VTE may receive certain treatments or interventions to help reduce the likelihood of the formation of blood clots (known as thromboprophylaxis), including taking anticoagulants.

The label for Fragmin contains a boxed warning to alert health care professionals and patients that epidural or spinal hematomas (accumulation of blood that can mechanically compress the spinal cord) may occur in patients who are anticoagulated due to taking certain medications called low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia (injection near the spine) or undergoing spinal puncture (removing spinal fluid for testing). These hematomas may result in long-term or permanent paralysis. Health care professionals are advised to consider these risks when scheduling patients for spinal procedures as patients may be at a higher risk of developing VTE. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters, use of other drugs that affect hemostasis at the same time when using Fragmin, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors and other anticoagulants; history of traumatic or repeated epidural or spinal punctures; and a history of spinal deformity or surgery. The optimal timing between the administration of Fragmin and neuraxial procedures is not known. Health care professionals are advised to monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Health care professionals are advised to consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

The FDA granted this application Priority Review designation. Pfizer holds the application for Fragmin.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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