Dorzolamide HCI/Timolol Maleate Solution (Apotex) – particulate matter (2012)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
Brand
Apotex Inc.
Lot Codes / Batch Numbers
Lot #s: JN1060, JN1061, JN1062, Exp 06/12
Products Sold
Lot #s: JN1060, JN1061, JN1062, Exp 06/12
Apotex Inc. is recalling Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Ap due to Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026