Enforcement Report - Week of August 8, 2012
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Product Detail
| 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 |
|---|---|
| Recall Number | D-1439-2012 |
| Classification | Class II |
| Code Info | Lot #s: JN1060, JN1061, JN1062, Exp 06/12 |
| Product Distributed Qty | 119,794 Bottles |
| Reason For Recall | Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates. |
Event Detail
| Event Id | 62574 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Apotex Inc. |
| City | Toronto |
| State | Country | CA |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-30 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide and Puerto Rico |
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