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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 2 oz - Catalog #MSC098502, Lot #: (L)12090411 & 4 oz -Catalog #MSC098504, Lot #: (L)12120509 Class II 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. 1,401 cs/36/2 oz bottles & 78 cs/36/4 oz bottles F-1928-2014
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