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Recall Observatory FDA recall evidence

Drug product

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

D-1414-2012

June 14, 2012

Class II

Product summary

Firm
Kimberly-Clark Corporation
Event
Event 62418
Status
Terminated
Classification
Class II
Quantity
5268 Cassettes
Official record key
drug-enforcement:D-1414-2012

Official wording

Reason: Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.

Code information: SKU #12977-00 (Cassette - 1 Liter), Lot #: SA1229ANB; b) SKU #12979-00 (E-Cassette - 1.2 Liters), Lot #: SA1229ANA, Exp 08/13

Distribution pattern: Nationwide and Canada

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination