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Bacterial Infection News (Page 6)
Related terms: Infection, Bacterial
FDA Medwatch Alert: Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter
ISSUE: AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May...
FDA Medwatch Alert: Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira: Recall - Presence of Particulate Matter
ISSUE: Hospira is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a...
FDA Medwatch Alert: Clindamycin Injection ADD-Vantage Vials by Alvogen: Recall - Lack of Sterility Assurance
ISSUE: Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the...
FDA Medwatch Alert: Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter
ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by...
FDA Medwatch Alert: Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter
ISSUE: Teva Pharmaceuticals announced a voluntary recall of seven lots of Amikacin Sulfate Injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for the presence...
FDA Medwatch Alert: Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects
ISSUE: FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). Includes the following currently available fluoroquinolones:...
FDA Approves New Formulation of Minocin (minocycline) for Injection
PARSIPPANY, N.J.--(BUSINESS WIRE)--Apr. 20, 2015-- The Medicines Company (NASDAQ:MDCO) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug...
FDA Medwatch Alert: Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit
ISSUE: Hospira, Inc. issued a voluntary nationwide user-level recall of one lot of Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g Vancomycin (Sterile Powder), NDC 0409-6533-01, Lot...
Aqua Pharmaceuticals Announces FDA Approval of Acticlate (doxycycline hyclate USP) Tablets
West Chester, Pa. — July 28, 2014 West Chester-based Aqua Pharmaceuticals, an Almirall company, today announces the U.S. Food and Drug Administration (FDA) approval of the NDA for Acticlate (...
FDA Medwatch Alert: Cefepime For Injection, USP And Dextrose Injection, USP By B. Braun Medical Inc.: Recall - Visible Particulate Matter
ISSUE: B. Braun Medical Inc. is voluntarily recalling one lot of 1g Cefepime for Injection USP and Dextrose Injection USP (Lot H3A744, catalog 3193-11) to the consumer level. The 1g Cefepime for ...
FDA Medwatch Alert: Cubicin (daptomycin for injection): Recall - Glass Particulate Matter Present in Four Lots
ISSUE: Cubist has notified customers by letter and phone of the voluntary recall of four lots of Cubicin (daptomycin for injection) due to the presence of particulate matter found in a number of...
FDA Medwatch Alert: Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall - Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution
ISSUE: Apotex Corp. notified healthcare professionals it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 15 lots of Piperacillin and Tazobactam for...
FDA Medwatch Alert: Benzalkonium Chloride Antiseptic Wipes by Dukal: Recall - Potential Microbial Contamination
ISSUE: Dukal Corporation announced a U.S. voluntary nationwide recall of selected lots of benzalkonium chloride swabs and antiseptic wipes manufactured for Dukal by Jianerkang Medical Dressing Co....
FDA Medwatch Alert: Cefepime:Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment
[Posted 6/26/2012] Issue: There have been cases of a specific type of seizure called nonconvulsive status epilepticus associated with the use of cefepime, primarily in patients with renal impairment...
FDA Medwatch Alert: Zithromax (azithromycin): FDA Statement on risk of cardiovascular death
ISSUE: FDA notified healthcare professionals that it is aware of the study published in the New England Journal of Medicine May 17, 2012 reporting a small increase in cardiovascular deaths, and in t...
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