34 FDA recalls mention Timolol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Timolol.
Reason Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Reason Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Reason Lack of Assurance of Sterility
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.
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.
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.
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
Reason Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Reason Defective container; yellow colored spike from cap lodged in the nozzle
Reason Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Reason Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf…
Reason Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Reason CGMP Deviations:
Reason Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile…
Reason Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile…
Reason Subpotent Drug
Reason Subpotent Drug
Reason cGMP Deviations
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