Class II · Moderate risk Ongoing
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing…
Reason Temperature Abuse
Is Ofloxacin recalled?
61 FDA recalls mention Ofloxacin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ofloxacin.
Class II · Moderate risk Ongoing
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC…
Reason Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk Ongoing
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC…
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk Ongoing
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma…
Reason Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk Ongoing
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC…
Reason Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk Terminated
Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540…
Reason Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class II · Moderate risk Ongoing
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake…
Reason CGMP Deviations:
Class II · Moderate risk Terminated
Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmaceuticals, NDC 69238-1615-3
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-656-05
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc., NDC 61314-0656-10
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/…
Reason CGMP Deviations
Class II · Moderate risk Terminated
CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count…
Reason CGMP Deviations
Class II · Moderate risk Terminated
CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75; RX; DROPS
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Completed
Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL, Altaire Pharmaceuticals, Inc Aquebogue, NY 11931 NDC…
Reason Lack of Assurance of Sterility
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