Status
Terminated
Drug Enforcement D-225-2013
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Classification
Class II
Report Date
April 3, 2013
Termination Date
May 12, 2014
Product Information
- 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.
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Location & Firm
- Recalling firm
- CareFusion 213, LLC
- Address
-
1550 Northwestern Drive
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-225-2013
- Event ID
- 64583
- Recall initiation date
- March 4, 2013
- Center classification date
- March 28, 2013
- 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.
- More code info
- —