Class III · Low risk
Bimatoprost Ophthalmic Solution 0.03%
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Eye Drops & Ophthalmic Recalls
Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.
673 recalls in this category, newest first.
Class II · Moderate risk
BromSite (bromfenac ophthalmic solution)
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Class II · Moderate risk
Lidocaine/Epinepherine liquid 1%/ 1:1000
Lack of sterility assurance.
Class III · Low risk
COSOPT Ophthalmic Solution
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Class II · Moderate risk
Prednisolone and Bromfenac Ophthalmic Solution
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Bromfenac
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%
Lack of sterility assurance.
Class II · Moderate risk
Acetylcysteine Ophthalmic Solution
Lack of sterility assurance.
Class I · High risk
Lubrisine eye drops
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Class III · Low risk
Prednisolone and Gatifloxacin Ophthalmic Solution
Presence of precipitate
Class II · Moderate risk
Gentamicin Sulfate Ophthalmic Solution
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Class II · Moderate risk
Cyclosporine 1% Human Eye Drops
Lack of Process Controls
Class III · Low risk
Azelastine HCl Ophthalmic Solution 0.05%
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Class II · Moderate risk
Medroxprogesterone 1% Ophthalmic Solution
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Eyewash Purified water 98.3%
CGMP Deviations
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class III · Low risk
Atropine Sulfate Ophthalmic 1% Solution
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class III · Low risk
Cefuroxime
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Class II · Moderate risk
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
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