Why it was recalled
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Product description
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
Lot numbers, UPCs & expiration codes
Lot #: 71132, Expiry: 02/2017
Where it was sold
Nationwide in U.S.
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-1442-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 13, 2013
- FDA report date
- Jul 23, 2014
- Quantity
- 23,000 Applicators
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CareFusion 213, LLC
Original FDA data
Every field from FDA enforcement report D-1442-2014, exactly as published.
Show all FDA fields
- City
- El Paso
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 68566
- Address
- 1550 Northwestern Drive
- Code information
- Lot #: 71132, Expiry: 02/2017
- Postal code
- 79912-8000
- Report date
- Jul 23, 2014
- Product type
- Drugs
- Recall number
- D-1442-2014
- Classification
- Class II
- Recalling firm
- CareFusion 213, LLC
- Product quantity
- 23,000 Applicators
- Termination date
- Apr 22, 2015
- Reason for recall
- Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
- Distribution pattern
- Nationwide in U.S.
- Recall initiation date
- Jun 13, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2014