Class I · High risk
Delsam Pharma's Artificial Eye Ointment
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
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
Clear Eyes
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Class II · Moderate risk
Delsam Pharma's ARTIFICIAL TEARS
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Class I · High risk
Delsam Pharma's ARTIFICIAL TEARS
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class II · Moderate risk
Artificial Tears
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Class I · High risk
Artificial Tears
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Class II · Moderate risk
Testosterone 3%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Tacrolimus 0.03% Oph Solution Tacrolimus 0.1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Acetylcysteine 10% Ophthalmic Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
5-Fluorouracil 1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class III · Low risk
Timolol Maleate Ophthalmic Solution
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Class II · Moderate risk
Timolol-Latanoprost
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution
cGMP deviation: discontinue of stability support for product.
Class II · Moderate risk
Tobramycin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Tobramycin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Sodium Chloride Ophthalmic Ointment
CGMP Deviations:
Class II · Moderate risk
Proparacaine Hydrochloride Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Proparacaine Hydrochloride Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Olopatadine HCL Ophthalmic Solution
CGMP Deviations:
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