Enforcement Report - Week of September 26, 2012
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Product Detail
| Product Description | Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788 --- NDC 65517-00031 |
|---|---|
| Recall Number | D-1676-2012 |
| Classification | Class II |
| Code Info | Antiseptic wipes shipped since July 02, 2009. Lots: JT34808, JT08209, JT15209, JT32809, JT00610, JT27610, JT05311, JT18211, JT22711-1, JT26411, JT01012, JT00610, JT14511, JT22011, 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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