Enforcement Report - Week of September 26, 2012
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Product Detail
| Product Description | ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA |
|---|---|
| Recall Number | D-1675-2012 |
| Classification | Class II |
| Code Info | Antiseptic wipes shipped since July 02, 2009. Lots: JT14509, JT15209, JT20609, JT20909, JT23709, JT27809, JT32809, JT00710, JT15810, JT18310, JT18810, JT23210, JT25810, JT27610, JT31510, JT35610, JT35911, JT04811, JT05311, JT11811, JT15211, JT15911, JT18211, JT18211, JT21511-1, JT26311, JT30711, JT22011-1, JT01012, JT04112, JT06512, JT07512, JT07710, JT14509, JT15209, JT21409, JT20609, JT33009, JT00710, JT18810, JT23210, JT35911, JT05311, JT11811, JT26311, JT01012, JT14509, JT15209, JT20609, JT15209, JT23709, JT27809, JT00710, JT00710, JT18310, JT18810, JT23210, JT23210, JT27610, JT31510, JT05809, JT14509, JT15209, JT21209, JT27809, JT12510, JT15810, JT18310, JT11811, JT13211, JT15911, JT35911, JT01012, JT30711 |
| Product Distributed Qty | |
| Reason For Recall | Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer) |
Event Detail
| Event Id | 62320 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Dukal Corp. |
| City | Ronkonkoma |
| State | NY | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-14 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Nationwide |
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