Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22 — Class II drug recall D-1439-2012
Terminated recall by Apotex Inc., reported 2012-08-08, distributed nationwide. Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
| Recall number | D-1439-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., Toronto, N/A, Canada |
| Recall initiated | 2012-04-30 |
| Classified | 2012-08-02 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2013-09-19 |
| Distributed | Nationwide (US) |
| Quantity | 119,794 bottles |
| Reason classes | specification failure |
| Lot numbers | 06/12, JN1060, JN1061, JN1062 |
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
Reason for recall
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1439-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.