Class II · Moderate risk Ongoing
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705…
Reason Presence of particulate matter - Glass like particles.
Is Moxifloxacin recalled?
38 FDA recalls mention Moxifloxacin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Moxifloxacin.
Class II · Moderate risk Ongoing
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC…
Reason Presence of particulate matter - Glass like particles.
Class II · Moderate risk Ongoing
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852…
Reason Presence of particulate matter - Glass like particles.
Class II · Moderate risk Ongoing
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis…
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk Ongoing
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial…
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk Terminated
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only…
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B…
Reason Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Class II · Moderate risk Ongoing
Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive…
Reason cGMP deviation: discontinue of stability support for product.
Class II · Moderate risk Ongoing
Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th…
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Class II · Moderate risk Terminated
Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo…
Reason Failed impurities/degradation specifications
Class II · Moderate risk Terminated
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark…
Reason Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Class II · Moderate risk Terminated
Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit…
Reason Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Class III · Low risk Terminated
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by…
Reason Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Class II · Moderate risk Terminated
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global…
Reason Lack of Assurance of Sterility
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.