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.
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.
Lot numbers, UPCs & expiration codes
All lots with expiry between 07/11 to 08/14.
Where it was sold
Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-229-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 4, 2013
- FDA report date
- Apr 3, 2013
- Quantity
- 544,500 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CareFusion 213, LLC
Original FDA data
Every field from FDA enforcement report D-229-2013, exactly as published.
Show all FDA fields
- City
- El Paso
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 64583
- Address
- 1550 Northwestern Drive
- Code information
- All lots with expiry between 07/11 to 08/14.
- Postal code
- 79912-8000
- Report date
- Apr 3, 2013
- Product type
- Drugs
- Recall number
- D-229-2013
- Classification
- Class II
- Recalling firm
- CareFusion 213, LLC
- Product quantity
- 544,500 kits
- Termination date
- May 12, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
- Recall initiation date
- Mar 4, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 28, 2013