Status
Terminated
Drug Enforcement D-229-2013
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
- 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.
- Product quantity
- 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.
- 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-229-2013
- Event ID
- 64583
- Recall initiation date
- March 4, 2013
- Center classification date
- March 28, 2013
- Code info
- All lots with expiry between 07/11 to 08/14.
- More code info
- —