Status
Terminated
Drug Enforcement D-1439-2012
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Classification
Class II
Report Date
August 8, 2012
Termination Date
September 19, 2013
Product Information
- 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
- Product quantity
- 119,794 Bottles
- Reason for recall
- Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Apotex Inc.
- Address
-
150 Signet Drive, N/A
Canada - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1439-2012
- Event ID
- 62574
- Recall initiation date
- April 30, 2012
- Center classification date
- August 2, 2012
- Code info
- Lot #s: JN1060, JN1061, JN1062, Exp 06/12
- More code info
- —