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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 FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS 66211.
Recall Number D-229-2013
Classification Class II
Code Info All lots with expiry between 07/11 to 08/14.
Product Distributed Qty 544,500 kits
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
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