Class II · Moderate risk Terminated
Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset Therapeutics, Inc., NDC 7006919101
Reason cGMP deviations: Temperature abuse
Eye Drops & Ophthalmic Recalls
Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.
662 recalls in this category, newest first.
Class II · Moderate risk Terminated
Tropicamide Ophthalmic Solution, USP 1%, 3 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131435502
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%, 10 mL bottle, Rx only, MFG: Sandoz Pharma, NDC…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-637-05
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-36
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
Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55
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
Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, MFG:Sandoz Pharma, NDC 61314-665-05
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL), Rx only, Mfd for: Alcon…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
Reason cGMP deviations: Temperature abuse
Class III · Low risk Terminated
Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured…
Reason Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Class II · Moderate risk Terminated
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV…
Reason Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification…
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 III · Low risk Terminated
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA…
Reason Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug…
Class II · Moderate risk Terminated
Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles…
Reason Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the…
Class II · Moderate risk Terminated
Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe…
Reason Lack of Assurance of Sterility
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