COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only…
Reason Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
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 Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Reason Failed Impurities/Degradation Specifications.
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients…
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients…
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients…
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients…
Reason Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
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