Class II · Moderate risk Terminated
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC…
Reason Defective Container: Vials may be missing stoppers.
Is Gentamicin recalled?
40 FDA recalls mention Gentamicin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Gentamicin.
Class II · Moderate risk Terminated
GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Class II · Moderate risk Terminated
GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Class II · Moderate risk Terminated
FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S…
Reason Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the…
Class II · Moderate risk Terminated
Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution For Office…
Reason Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial…
Class II · Moderate risk Ongoing
Gentamicin Sulfate 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk Ongoing
Gentamicin 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk Ongoing
Gentamicin 300 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk Ongoing
Gentamicin 0.3% Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk Terminated
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only…
Reason Presence of Particulate Matter: visible particles were identified floating in the primary container.
Class II · Moderate risk Terminated
Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk Terminated
Gentamicin Injection, all strengths and all presentations including a) Gentamicin 40 mg/2 mL, b) Gentamicin 40 mg/30 mL, c)…
Reason Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…
Class II · Moderate risk Terminated
Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Class II · Moderate risk Terminated
Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk Terminated
GENTAMICIN 40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML; GENTAMICIN / SODIUM BICARBONATE (STERILE) 480MG/LITER…
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because…
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