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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211.
Recall Number D-224-2013
Classification Class II
Code Info All lots distributed between 01/10 to 02/13
Product Distributed Qty 698,000 applicators
Reason For Recall Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

Event Detail

Event Id 64583
Product Type Drugs
Status Ongoing
Recalling Firm CareFusion 213, LLC
City El Paso
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom