Drug Enforcement D-1675-2012

Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)

Status

Terminated

Classification

Class II

Report Date

September 26, 2012

Termination Date

June 21, 2013

Product Information

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
Product quantity
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Reason for recall
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Dukal Corp.
Address
2 Fleetwood Ct

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-1675-2012
Event ID
62320
Recall initiation date
June 14, 2012
Center classification date
September 17, 2012
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
More code info
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