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
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.
Lot numbers, UPCs & expiration codes
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.
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-225-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 4, 2013
- FDA report date
- Apr 3, 2013
- Quantity
- 3,032,000 applicators
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CareFusion 213, LLC
Original FDA data
Every field from FDA enforcement report D-225-2013, 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
- 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.
- Postal code
- 79912-8000
- Report date
- Apr 3, 2013
- Product type
- Drugs
- Recall number
- D-225-2013
- Classification
- Class II
- Recalling firm
- CareFusion 213, LLC
- Product quantity
- 3,032,000 applicators
- 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
- 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.
- 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