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Surgery News (Page 13)
FDA Approves Otiprio (ciprofloxacin otic suspension) for the Treatment of Pediatric Patients Undergoing Tympanostomy Tube Placement Surgery
SAN DIEGO, Dec. 11, 2015 (GLOBE NEWSWIRE) – Otonomy, Inc. (Nasdaq:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and...
FDA Medwatch Alert: Compounded Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning - Do Not Use
ISSUE: FDA is alerting health care professionals not to administer to patients compounded or repackaged drugs that have been stored in 3 milliliter (ml) and 5ml syringes manufactured by...
FDA Medwatch Alert: 0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port
ISSUE: Baxter International Inc. announced a voluntarily recall of one lot of intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter and ...
FDA Medwatch Alert: 0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter
ISSUE: Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. The...
FDA Approves Raplixa (fibrin sealant [human]) to Control Bleeding During Surgery
April 30, 2015 – The U.S. Food and Drug Administration today approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control...
FDA Medwatch Alert: 0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter
ISSUE: Baxter International Inc. initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is...
FDA Medwatch Alert: 10 Percent Neutral Buffered Formalin by Richard-Allan Scientific: Class I Recall - May Contain Incorrect Concentration of Formalin
ISSUE: Richard-Allan Scientific discovered defective products returned from several customers were found to have from 0 percent to 3 percent Formalin content instead of the required 10 percent. A ...
FDA Medwatch Alert: Baxter 5 Percent Dextrose Injection, USP And 0.9 Percent Sodium Chloride Injection, USP Intravenous (IV) Solutions: Recall - Particulate Matter In Solution
Product Name Product Code NDC Container Size Lot # Exp. 5% Dextrose Injection, USP 2B0089 0338-0017-38 100 mL P285288 Nov-13 0.9% Sodium Chloride Injection, USP 2B1308 0338-0049-31 50 mL...
FDA Medwatch Alert: Hydroxyethyl Starch Solutions: FDA Safety Communication - Boxed Warning on Increased Mortality and Severe Renal Injury and Risk of Bleeding
ISSUE: FDA has analyzed recent data that indicate an increased risk of (i) mortality and renal injury requiring renal replacement therapy in critically ill adult patients, including patients with...
FDA Medwatch Alert: The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products
ISSUE: The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of S...
FDA Medwatch Alert: Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container: Recall - Brass Particulates
ISSUE: Hospira, Inc. notified healthcare professional of a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 1000 mL, Flexible Container, NDC 0409-7983-09....
FDA Medwatch Alert: Codeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication - Risk of Rare, But Life-Threatening Adverse Events or Death
[UPDATED 02/20/2013] FDA notified the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy (surgery to r...
FDA Approves Evarrest Fibrin Sealant Patch
SOMERVILLE, N.J., Dec. 7, 2012 /PRNewswire/ -- Ethicon Biosurgery, Division of Ethicon, Inc., a worldwide leader in hemostasis and sealing solutions, announced today that the U.S. Food and Drug ...
FDA Medwatch Alert: Ameridose, LLC: Recall of Unexpired Products in Circulation
[Posted 10/31/2012] ISSUE: The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in ...
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