This voluntary recall was initiated because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates. Potential adverse events after intravenous administration of solutions containing particulates, may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation.
American Regent Initiates Voluntary Nationwide Recall of Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials
American Regent is conducting a nationwide voluntary recall of the three lots listed below of the following product:
Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL, Multiple Dose Vials NDC # 0517-0648-25
FDA, EMA announce pilot for parallel assessment of Quality by Design applications
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design (QbD), of new drug marketing applications that are submitted to both agencies.
American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4% 30 mL Single Dose Vials and 100 mL Pharmacy Bulk Packs
This voluntary recall was initiated because some of the vials of these lots may contain visible particulates. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if these lots of product are administered to patients.
FDA approves imaging agent for central nervous system scans
The U.S. Food and Drug Administration today approved Gadavist (gadobutrol), a gadolinium-based contrast agent, for use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system.
D&M Smoked Fish, Inc. Issues an Alert on Uneviscerated Shmaltz Herring and Cold Smoked Sprats
D&M Smoked Fish, Inc. located in Queens, New York, is recalling Haifa brand Schmaltz Herring with the Lot # 51 and Cold Smoked Sprats Lot #54 because the product was found to be uneviscerated. The lot for Schmaltz Herring being recalled packed in white plastic pales with salt brine and was distributed through following food retailers in the NY area on or after February 27.
Maryland sprout processor enters into consent decree with the FDA
The Food and Drug Administration announced today that Vegi-Pak Farm LLC of Mt. Airy, Md., and its president, Sun Ja Lee, and general manager, Brian W. Lee, signed a consent decree recently prohibiting them from processing, holding and distributing bean sprouts due to their failure to comply with federal food safety laws.
Vegi-Pak Farm grows, processes, packages and distributes ready-to-eat soybean sprouts and holds and distributes tofu and mung bean spouts. The products are sold to markets in Maryland, Virginia and Washington, D.C. DSK
Faribault Foods Announces Voluntary Recall of Field Day Organic Garbanzo Beans Due to Mislabeling and Undeclared Allergens
Faribault Foods, Inc. announced today a voluntary recall of Field Day Organic Garbanzo Beans because some cans with this label may contain Minestrone soup. Faribault Foods received two reports that cans of the Organic Garbanzo Beans contain Minestrone soup (a vegetable and pasta soup).
PIERRE FOODS Voluntarily Recalls 320 Cases Of Pierre TM pb jamwich, LOT 0068035 From Giant-Carlisle Stores IN MD, PA, VA AND WV
Pierre Foods is voluntarily recalling one lot, 320 cases of PierreTM pb jamwich, crustless peanut butter and strawberry jam sandwiches, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
ONE World Enterprises Recalls O.N.E. Coconut Water Due To Mold
ONE World Enterprises, LLC is recalling O.N.E. Coconut Water, packaged in 11.2 oz Tetra Pak cartons with Lot code 12E1004, UPC # 894991001104 and Sell-by date of May 1, 2011, due to the potential oxidation of the product that may permit the growth of mold. The affected product is isolated to a single lot number and the company is currently utilizing Corrective And Preventative Action (CAPA) procedures to identify why this problem exists, which was discovered after receiving a small number of consumer complaints.
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