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 Ciprofloxacin recalled?
28 FDA recalls mention Ciprofloxacin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ciprofloxacin.
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
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
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 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
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
Class III · Low risk Terminated
Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag…
Reason Superpotent
Class II · Moderate risk Terminated
Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc…
Reason Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and…
Class III · Low risk Terminated
Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech…
Reason Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Class III · Low risk Terminated
Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For…
Reason Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or…
Class II · Moderate risk Terminated
CIPROFLOXACIN 400MG / D5W 200ML ACCUFLO, Packaged in 3 200 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little…
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Ciprofloxacin HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical…
Reason Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Class II · Moderate risk Terminated
Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine…
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
CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by…
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Class II · Moderate risk Terminated
Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC…
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC…
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
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