Multi-event June 2012 FDA Recall Drug by Kimberly-clark Corporation
This Multi-event Class II drug recall was voluntarily initiated by Kimberly-clark Corporation on June 14, 2012 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products; the affected lots were found to be contaminated with bacterium, burkholderia cepacia complex.. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1414-2012
Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
06-14-2012
07-18-2012
5268 Cassettes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kimberly-Clark Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Canada
04-09-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# SKU #12977-00 (Cassette - 1 Liter)
Lot# : SA1229ANB; b) SKU #12979-00 (E-Cassette - 1.2 Liters)
Lot# : SA1229ANA, Exp 08/13
Recall Number: D-1415-2012
Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
06-14-2012
07-18-2012
8994 Bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kimberly-Clark Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Canada
04-09-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 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
