6 FDA recalls mention Dorzolamide. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dorzolamide.
Reason Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Subpotent Drug
Reason Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Reason Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
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