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Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit, Due to a Mix-Up of the Diluent Included in the Kit
… (“Azurity”) is voluntarily recalling one lot of Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq®”) to the consumer level, … instead of the Firvanq diluent bottle. Risk Statement: Vancomycin may not be completely solubilized in the FIRST-PPI …
A case of hemorrhagic occlusive retinal vasculitis (HORV) following intraocular injections of a compounded triamcinolone, moxifloxacin, and vancomycin formulation
… of patients who have received intraocular injections of vancomycin (anti-infective) formulations toward the end of … (steroid), moxifloxacin (anti-infective), and vancomycin formulation. Adverse Event FDA received an adverse … of a compounded triamcinolone, moxifloxacin, and vancomycin (TMV) formulation in each eye at the conclusion of …
Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, Due To The Presence of Visible Glass Particulates
… a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride Injection, USP, 1.5 g/vial Single … reports of any adverse events related to this recall. Vancomycin Hydrochloride is an antibiotic indicated for the … strains of methicillin-resistant staphylococci. Vancomycin Hydrochloride is effective in the treatment of …
Leiters Health Issues Voluntary Nationwide Recall of Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Due to Potential for Superpotent Drug
… listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV … 3/19/2024 2331190 3/26/2024 2331429 4/28/2024 F3206 Vancomycin HCl 1.25 g PF added to 0.9% Sodium Chloride 250 mL … 2331191 2/24/2024 2331258 3/3/2024 2331317 3/15/2024 F3208 Vancomycin HCl 1.5 g PF added to 0.9% Sodium Chloride 250 mL …
Hospira Issues A Voluntary Nationwide Recall For One Lot Of Vancomycin Hydrochloride for Injection, USP Due To The Presence of Particulate Matter Within a Single Vial
… a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: … every step in the manufacturing and supply chain process. Vancomycin Hydrochloride is indicated for the treatment of … strains of methicillin-resistant staphylococci. Vancomycin Hydrochloride is effective in the treatment of …
Hospira Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial Due to The Presence of Particulate Matter Within a Single Vial
… a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC … every step in the manufacturing and supply chain process. Vancomycin Hydrochloride is indicated for the treatment of … strains of methicillin-resistant staphylococci. Vancomycin Hydrochloride is effective in the treatment of …
Vancomycin – Injection products
… pneumoniae … Center for Drug Evaluation and Research … Vancomycin – Injection products … Vancomycin – Injection products …
Amneal Pharmaceuticals, LLC. Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, Due to the Potential for Some Bottles to be Super Potent Which May be Harmful
… is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL … the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some …
Characterizing Phage Resistance Mutations in Vancomycin Resistant Enterococcus
… spp. Our group has identified several mutants of Vancomycin resistant Enterococcus that have acquired … strain … Characterizing Phage Resistance Mutations in Vancomycin Resistant Enterococcus …
BAM Media M192a: Modified Buffered Peptone water with pyruvate (mBPWp) and Acriflavin-Cefsulodin-Vancomycin (ACV) Supplement
… Sterilize by autoclaving. Acriflavin-Cefsulodin-Vancomycin (ACV) Supplement for mBPWp Supplement Conc. in … g/ 500 mL 1 mL Cefsulodin 10mg/L 1.125 g/ 500 mL 1 mL Vancomycin 8mg/L 0.90 g/ 500 mL 1 mL Filter, sterilize. Add … water with pyruvate (mBPWp) and Acriflavin-Cefsulodin-Vancomycin (ACV) Supplement …
Immunological and Microbial Responses to Bacteriophage Therapy Targeting Vancomycin-Resistant Enterococcus Colonization
… and Microbial Responses to Bacteriophage Therapy Targeting Vancomycin-Resistant Enterococcus Colonization …
Immunological and Microbial Responses to Bacteriophage Therapy Targeting Vancomycin-Resistant Enterococcus Colonization
… and Microbial Responses to Bacteriophage Therapy Targeting Vancomycin-Resistant Enterococcus Colonization …
Characterizing Phage Resistance Mutations in Vancomycin Resistant Enterococcus
… … Characterizing Phage Resistance Mutations in Vancomycin Resistant Enterococcus …
FDA Rationale for Recognition Decision: Daptomycin
… (STIC) for daptomycin for Enterococcus faecalis (including vancomycin-susceptible and vancomycin-resistant isolates) based on a dosing regimen of 4 … BPs should be revised only for E. faecalis (including vancomycin-susceptible and vancomycin-resistant isolates). …
FDA Rationale for Recognition Decision: Daptomycin
… (cSSSI) including those caused by Enterococcus faecalis (vancomycin-susceptible isolates only). In 2006 the indication … breakpoints (published in Sep 2020) E. faecalis (including vancomycin-resistant isolates) ≤2 - 4 ≥8 S= susceptible; … recognition for daptomycin and E. faecalis (including vancomycin-resistant isolates) to Enterococcus spp. other …
An Electronic Approach for Post-Market Safety Monitoring for Antibiotic-Associated Adverse Events
… methods to detect kidney damage in patients related to vancomycin, a commonly prescribed intravenous antibiotic, … Cosgrove SE, Klein EY. An Electronic Algorithm to Identify Vancomycin-Associated Acute Kidney Injury. Open Forum Infect … Generalizability of an Electronic Algorithm to Identify Vancomycin-Associated Acute Kidney Injury. Poster …
Drug Trials Snapshots: BAXDELA
… to the standard antibacterial combination therapy of vancomycin and aztreonam in stopping the spread of ABSSSI. … with ABSSSI in Trial 1 and Trial 2 Trial BAXDELA IV Vancomycin+Aztreonam IV Treatment Difference** (2-sided 95% … (78.2%) 266 (80.9%) -2.6 (-8.8, 3.6) BAXDELA IV and oral Vancomycin+Aztreonam IV Treatment Difference** (2-sided 95% …
Kidon Sung
… Feb 11, 4(1): e01396-15. Genomic Sequence of a Clinical Vancomycin-Resistant Reference Strain, Enterococcus faecalis … Diversity of Tn1546-Like Elements in Clinical Isolates of Vancomycin-Resistant Enteroccoci . Sung K., Khan S. and Nawaz … Agents. 2008 Jun, 31(6):549-554. Heteroresistance to Vancomycin and Novel Point Mutations in Tn1546 of …
Coronavirus (COVID-19) Update: November 23, 2021
… the FDA approved an abbreviated new drug application for vancomycin hydrochloride for injection , indicated to treat … or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. The side effects of vancomycin hydrochloride for injection include diarrhea, …
Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance
… (PF) 5% 05446-1680-01 TRYPAN BLUE (PF) 0.03% 05446-1200-01 VANCOMYCIN HCL (PF) 10 MG/ML 05446-0736-01 VANCOMYCIN HCL (PF) 1250 MG/250ML 05446-1456-01 VANCOMYCIN HCL (PF) 1500 MG/512ML 05446-1458-01 VANCOMYCIN …
Drug Trials Snapshots: ZEVTERA
… assigned to receive either ZEVTERA (335 subjects) or vancomycin plus aztreonam (the comparator; 344 subjects). The … ZEVTERA (94 subjects) or a cephalosporin with optional vancomycin (the comparator; 44 subjects). The primary … objective of demonstrating non-inferiority of ZEVTERA to vancomycin plus aztreonam for the primary endpoint. Table 3. …
Saeed Khan
… Diversity of Tn1546-Like Elements in Clinical Isolates of Vancomycin-Resistant Enterococci . Sung K., Khan S. and Nawaz … Agents. 2008 Jun, 31(6):549-54. Heteroresistance to Vancomycin and Novel Point Mutations in Tn 1546 of … from Poultry and Dairy Farms: Detection of Virulence and Vancomycin Resistance Gene Markers by PCR . Khan S., Nawaz …
Withdrawn | Infectious Disease Accelerated Approvals
… Synercid (dalfopristin/quinupristin) For the treatment of vancomycin-resistant enterococcus faecium (VREF) 9/21/1999 …
Drug Trials Snapshot: DALVANCE (dalbavancin)
… they were treated with DALVANCE or the comparison drug (Vancomycin/linezolid). Age: The frequency of side … given DALVANCE and 653 others received a combination of Vancomycin and linezolid, which has been the standard therapy … were taking DALVANCE and which patients were taking Vancomycin/linezolid, until after the drug trial was …
Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Linezolid Injection 600mg/300ml, Due to Presence White Particulate Matter that has been Identified as Mold
… Uncomplicated skin and skin structure infections (1.2); Vancomycin-resistant Enterococcus faecium infections (1.3). …