Status
Terminated
Drug Enforcement D-1414-2012
Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Classification
Class II
Report Date
July 18, 2012
Termination Date
April 9, 2013
Product Information
- Product description
- 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
- Product quantity
- 5268 Cassettes
- Reason for recall
- Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide and Canada
Location & Firm
- Recalling firm
- Kimberly-Clark Corporation
- Address
-
1400 Holcomb Bridge Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1414-2012
- Event ID
- 62418
- Recall initiation date
- June 14, 2012
- Center classification date
- July 12, 2012
- Code info
- SKU #12977-00 (Cassette - 1 Liter), Lot #: SA1229ANB; b) SKU #12979-00 (E-Cassette - 1.2 Liters), Lot #: SA1229ANA, Exp 08/13
- More code info
- —