FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
October 2, 2009
The U.S. Food and Drug Administration (FDA) is alerting healthcare providers of a change to the United States Pharmacopeia (USP) monograph for heparin, effective October 1, 2009. Manufacturers will not begin shipping heparin products manufactured and tested according to the new USP monograph until October 8th or later. This change—largely in response to the 2007-2008 heparin contamination problem—will include a new USP reference standard and test method that is used to determine the potency of the drug. The new test method, unlike the previous method, is able to detect impurities that may be present in heparin. The monograph change will also harmonize the USP unit dose with the WHO International Standard (IS) unit dose.
Bone Fractures: Symptoms or Side Effects?
October 1, 2009
Bone fractures are often a symptom of conditions or diseases such as osteoporosis, but could also be side effects associated with certain medications. Below is a list of diseases and conditions associated with symptoms like bone fractures, as well as a list of medications related to similar side effects.
We are not medical professionals, and these may not be comprehensive lists. Please contact your doctor if you are experiencing any of the following symptoms or side effects, or similar health issues.
Bleeding and Bruising Easily: Symptoms or Side Effects?
September 26, 2009
Bruising and bleeding are often symptoms of conditions or diseases such as hemophilia, but could also be side effects associated with certain medications. Below is a list of diseases and conditions associated with symptoms like bleeding and bruising easily, as well as a list of medications related to similar side effects.
FDA Opens Branch in China
November 20, 2008
In response to millions of dangerous products from China finding their way onto American store shelves, the US Food and Drug Administration made history today by opening the first foreign FDA office in Beijing. Better late than never.
Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters
May 16, 2008
CONTACT: ATRIUM 1-800-5-ATRIUM
Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products
May 15, 2008
CONTACT: DANIEL BEACH PUBLIC RELATIONS 763-505-2603
FDA Blames Failure to Inspect Chinese Drug Makers on Shortage of Funds
May 2, 2008
After recent debacles like the Digitek recall this week, and the heparin recall last month, it is obvious that a major overhaul is needed in the way we inspect, approve of and import drugs from overseas pharmaceutical companies. It seems that perhaps, finally, the US government is starting to take this threat seriously. Joe Sheffer reports on the American Pharmacists Association website that the Food and Drug Administration (FDA) is asking for hundreds of millions per year to inspect foreign drug facilities.
Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin (March 28)
April 7, 2008
CONTACT: ERIC KRAUS 508-261-8305
FOR IMMEDIATE RELEASE — MANSFIELD, MASSACHUSETTS – MARCH 28, 2008 – COVIDIEN, FORMERLY TYCO HEALTHCARE, WAS RECENTLY NOTIFIED BY ITS SUPPLIER, SCIENTIFIC PROTEIN LABORATORIES LLC (SPL), OF A NATION-WIDE RECALL OF HEPARIN SODIUM USP ACTIVE PHARMACEUTICAL INGREDIENT. THE VOLUNTARY RECALL AFFECTS THE FOLLOWING 32 LOTS MANUFACTURED AND DISTRIBUTED BY COVIDIEN IN THE UNITED STATES.
B. Braun’s Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions (March 21)
March 22, 2008
CONTACT: STEPHANIE EULER, 908-276-4344 EXT. 213 SUSAN DENBY, 610-997-4856
FOR IMMEDIATE RELEASE –IRVINE, CA — MARCH 21, 2008 — B. BRAUN MEDICAL INC. WAS RECENTLY 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 THE FOLLOWING 23 FINISHED PRODUCT (FP) LOTS MANUFACTURED AND DISTRIBUTED BY B. BRAUN MEDICAL INC. NATIONWIDE AND TO CANADA.
American Health Packaging Announces a Recall of Approximately 1,400 Units of Heparin Sodium Vial Products as Part of Broader Baxter Recall (March 20)
March 22, 2008
CONTACT: MICHAEL N. KILPATRIC 610-727-7118
Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products (Feb. 28)
March 17, 2008
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.
FDA Drops The Ball Again – Chinese Drug Maker Not Inspected
February 16, 2008
The tainted blood thinner heparin, which was recalled in January, has been linked to four deaths in the US and about 350 other “complications”.
A recent report by Walt Bodanich and Jake Hooker of the New York Times reveals that the active ingredient in this blood thinner marketed by Baxter International was produced by a factory in China. No big surprise there.
Baxter Issues Urgent Recall on Heparin Sodium Injections
January 21, 2008
There have been an increasing number of reports of side-effects from certain lots of Heparin Sodium Injection 1000 units / mL in 10 and 30 mL vials.
Adverse reactions include stomach pain, low blood pressure, burning sensations, chest pain, diarrhea, dizziness, ineffectiveness, dyspepsia, flushing, headaches, hyperhidrosis, hypoesthesia, hypotension, lacrimation, loss of consciousness, nausea, extreme thirst, and other side effects.
Heparin Syringes Recalled
January 7, 2008
A nationwide recall has been announced on Pre-filled Heparin Lock Flush Solution USP (5 mL in 12 mL syringes) with Lot #070926H. The Heparin IV flush syringes have been found to be contaminated with Serratia marcescens, a bacterium that is resulting in patient infections. This type of bacterial infection can cause severe, life threatening or life altering injuries and can even be fatal.
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