Reported Apr 3, 2013 · Terminated
SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP),…
CareFusion 213, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CareFusion 213, LLC · 1550 Northwestern Drive · El Paso, TX · 79912-8000
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
260261 | 200-count applicators (Net 0.67 mL each) per carton, , NDC 54365-161-01, CareFusion, Leawood, KS 66211 |
260431 | 3000-count applicators (Net 0.67 mL each) per case, , NDC 54365-151-01, CareFusion, Leawood, KS 66211; and |
| — | 3000-count applicators (Net 0.67 mL each) per case, Reorder TA6200, Manufactured for: Tri-State Hospital Supply Corporation, Howell, MI 48843. |
- Lot codes and dates
- 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.
- Amount recalled
- 3,032,000 applicators
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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