CLASS II Drug recall · Reported 8 Aug 2012 · FDA Enforcement Report
Dorzolamide HCI/Timolol Maleate Ophthalmic Solution recalled by Apotex
Apotex is recalling Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, For Topical, distributed nationwide in the US. The recall was initiated on 30 Apr 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1439-2012
- FDA event ID
- 62574
- Recalling firm
- Apotex, Toronto, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2012
- FDA classified
- 2 Aug 2012
- Reported
- 8 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Eye Drops
Timeline
| 30 Apr 2012 | Recall initiated by company | |
| 2 Aug 2012 | Classified by FDA | +94 days |
| 8 Aug 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Which lots are affected?
Lot #s: JN1060, JN1061, JN1062, Exp 06/12
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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