Why it was recalled
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Product description
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
Lot numbers, UPCs & expiration codes
Lot 52894, Product Code: 260400
Where it was sold
IL, MO, and NJ
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-004-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 23, 2012
- FDA report date
- Oct 10, 2012
- Quantity
- 576 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Carefusion 213, Llc
Original FDA data
Every field from FDA enforcement report D-004-2013, exactly as published.
Show all FDA fields
- City
- El Paso
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 62900
- Address
- 1550 Northwestern Dr
- Code information
- Lot 52894, Product Code: 260400
- Postal code
- 79912-8000
- Report date
- Oct 10, 2012
- Product type
- Drugs
- Recall number
- D-004-2013
- Classification
- Class II
- Recalling firm
- Carefusion 213, Llc
- Product quantity
- 576 Cartons
- Termination date
- Sep 11, 2013
- Reason for recall
- Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
- Distribution pattern
- IL, MO, and NJ
- Recall initiation date
- Apr 23, 2012
- Initial firm notification
- Letter
- Center classification date
- Oct 3, 2012