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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Product Detail

Product Description Medline Skintegrity Moisturizing Lotion, made with oatmeal, aloe & vitamin e, 2 & 4 oz btls, Manufactured in USA for Medline Industries, Inc., Mundelein, IL 60060 UPC 0 80196 75401 7
Recall Number F-1928-2014
Classification Class II
Code Info 2 oz - Catalog #MSC098502, Lot #: (L)12090411 & 4 oz -Catalog #MSC098504, Lot #: (L)12120509
Product Distributed Qty 1,401 cs/36/2 oz bottles & 78 cs/36/4 oz bottles
Reason For Recall Kutol Products Company is voluntarily recalling the affected products as they were found to be out of specification for Aerobic Plate Count and presence of gram negative bacteria. Specification for Aerobic Plate Count is < 100 cfu per gram with results for both affected product lots being Too Numerous To Count (TNTC). Specification for gram negative bacteria is "negative" with results for both affected product lots being "positive" for gram negative bacteria. The gram negative bacteria was identified as pseudomonas aeruginosa.

Event Detail

Event Id 68096
Product Type Cosmetics
Status Ongoing
Recalling Firm Kutol Products Co
City Sharonville
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Product was shipped to IN & KY.