D-1439-2012 Class II Terminated
FDA drug recall D-1439-2012 was initiated by Apotex Inc. on Apr 30, 2012 and is designated Class II. Reason for recall: Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates. The recall status is terminated (terminated Sep 19, 2013). Affected quantity: 119,794 Bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 8, 2012
- Initiation Date
- Apr 30, 2012
- Termination Date
- Sep 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 119,794 Bottles
Product description
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.
Distribution pattern
Nationwide and Puerto Rico
Code information
Lot #s: JN1060, JN1061, JN1062, Exp 06/12
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1439-2012
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026