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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 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net 0.67 mL each) per case, Cat. No 260431, NDC 54365-151-01, CareFusion, Leawood, KS 66211; and c) 3000-count applicators (Net 0.67 mL each) per case, Reorder TA6200, Manufactured for: Tri-State Hospital Supply Corporation, Howell, MI 48843.
Recall Number D-225-2013
Classification Class II
Code Info a) All lots with expiry between 02/12 to 10/15; b) All lots with expiry between 09/11 to 12/13; and c) All lots with expiry between 12/11 to 12/11.
Product Distributed Qty 3,032,000 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
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