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Anesthesia News (Page 3)
FDA Medwatch Alert: 0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter
ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail...
FDA Medwatch Alert: PharMEDium Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl): Recall - Presence of Glass Particulate Matter
[Posted 05/09/2016] Fresenius Kabi indicated in its recall notice that the presence of glass particulate matter in solution, if undetected and administered via the epidural route, could block drug...
Flamel Technologies Receives FDA Approval of Akovaz (ephedrine sulfate) for Surgical Hypotension
LYON, FRANCE--(Marketwired - May 2, 2016) - Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's New Drug Application (NDA)...
FDA Medwatch Alert: Lidocaine HCl Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates
ISSUE: Hospira, Inc. is recalling one lot of Lidocaine HCl Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user...
FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia
WOODCLIFF LAKE, N.J.(BUSINESS WIRE) July 23, 2014 – Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq:EGRX) today announced that the U. S. Food and Drug Administration (FDA) has approve...
FDA Medwatch Alert: Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates
[Posted 04/22/2014] ISSUE: Hospira, Inc. announced a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 10 mL, Single-dose Vial – P...
FDA Medwatch Alert: Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates
ISSUE: Hospira notified the public of a nationwide recall of seven lots of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL) to the user level due to a glass defect located on the interior...
FDA Medwatch Alert: Etomidate Injection/Pfizer-Mylan: Recall - Presence of Particulate Matter and/or Illegible and Missing Lot Number and/or Expiry Date
ISSUE: Agila Specialties notified medical care organizations of a nationwide recall to the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL – 10 mL and 20 mL (See the firm Press Release f...
FDA Medwatch Alert: CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action - Loss of Anesthetic Gases, Ventilation and Oxygenation
[Posted 01/01/2014] AUDIENCE: Anesthesiology, Risk Manager ISSUE: Vital Signs Devices, a GE Healthcare Company, has initiated a voluntary field corrective action of the disposable Multi Absorber ...
FDA Medwatch Alert: Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall - Presence of Particulate Matter
ISSUE: Hospira initiated a voluntary nationwide recall to the user level for one lot of Lidocaine HCl Injection, USP, 2%, 5 mL Single-Dose Vial (NDC 0409-2066-05), Lot 32-135-DD, expiration date...
FDA Medwatch Alert: Low Molecular Weight Heparins: Drug Safety Communication - Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis
ISSUE: The U.S. Food and Drug Administration (FDA) is recommending that health care professionals carefully consider the timing of spinal catheter placement and removal in patients taking...
FDA Medwatch Alert: Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected
ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of three lots of Vecuronium Bromide for Injection 10mg (NDC number 25021-657-10) manufactured by Mustafa Nevzat Ilac...
FDA Medwatch Alert: Hospira Propofol Injectable Emulsion: Recall - Glass Vial Defect
ISSUE: Hospira and FDA notified healthcare professional of a nationwide recall of three lots of Propofol Injectable Emulsion, 1%, 1g/100 mL, due to visible particles embedded in the glass to the user...
FDA Medwatch Alert: Vecuronium Bromide For Injection Preservative Free (Bedford Laboratories): Recall - Particulate Matter
[Posted 06/29/2012] ISSUE: Bedford Laboratories issued recall of Vecuronium Bromide For Injection, 20 mg vial – NDC #55390-039-10, Lot 2067134, Exp. Date 5/31/2013 - due to the discovery of pa...
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