Summary Company Announcement Date: August 18, 2020 FDA Publish Date: August 18, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Incorrect preservative (benzyl alcohol) Company Name: SCA Pharmaceuticals Brand Name: Brand Name(s) SCA Pharma Product Description: Product Description Heparin Sodium Compounded … [Read more...]
Search Results for: HEPARIN
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
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 … [Read more...]
Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters
CONTACT: ATRIUM 1-800-5-ATRIUM FOR IMMEDIATE RELEASE -- HUDSON, NEW HAMPSHIRE – MAY 12, 2008 – ATRIUM MEDICAL CORPORATION TODAY ANNOUNCED THAT IT IS INITIATING A VOLUNTARY AND PRECAUTIONARY RECALL OF SELECTED LOTS OF HYDRAGLIDE™ BRAND HEPARIN-COATED THORACIC DRAINAGE CATHETERS. LIMITED LOTS OF ATRIUM HEPARIN-COATED HYDRAGLIDE … [Read more...]
Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products
CONTACT: DANIEL BEACH PUBLIC RELATIONS 763-505-2603 FOR IMMEDIATE RELEASE -- MINNEAPOLIS – MAY 7, 2008 – MEDTRONIC, INC. TODAY ANNOUNCED THAT IT IS INITIATING A VOLUNTARY AND PRECAUTIONARY RECALL OF SELECTED PRODUCTS FEATURING THE CARMEDA BIOACTIVE SURFACE. THE AFFECTED DEVICES ARE DISPOSABLE PRODUCTS USED DURING CARDIOPULMONARY BYPASS … [Read more...]
Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin (March 28)
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 … [Read more...]
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