Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.
662 recalls in this category, newest first.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
Reason Failed Impurities/Degradation Specifications.
Reason Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Reason Failed Impurities/Degradation Specifications
Reason Chemical Contamination
Reason Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Reason Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Reason Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Reason Lack of Sterility Assurance
Reason Subpotent Drug: concentration of product is less than labeled amount.
Reason Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Failed Content Uniformity Specifications
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Reason Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Reason Presence of Particulate Matter
Reason Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or…
Reason Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the…
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