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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Event Detail

Event ID 62418
Product Type Drugs
Status Ongoing
Recalling Firm Kimberly-Clark Corporation
City Roswell
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-14
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide and Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076 a) SKU 34136-00; Lot #: SA2137SLA, SA2136SLB, Exp 05/13, SA2060SLB, Exp 02/14, SA2076SLB, SA2086SLC, SA2087SLA Exp 03/14, SA2131SLA, SA2135SLA, Exp 05/14 b) SKU 34135-00; Lot #: SA2086SLB, Exp 03/14 c) SKU 34111-00; Lot #: SA2086SLA, Exp 03/14, SA2122SLA, SA2123SLA, Exp 04/14 Class II Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex. 8994 Bottles D-1415-2012
Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076 SKU #12977-00 (Cassette - 1 Liter), Lot #: SA1229ANB; b) SKU #12979-00 (E-Cassette - 1.2 Liters), Lot #: SA1229ANA, Exp 08/13 Class II Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex. 5268 Cassettes D-1414-2012
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