Why it was recalled
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Product description
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
Lot numbers, UPCs & expiration codes
Product code 260415, Lot#: 48225
Where it was sold
Nationwide
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-1674-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 8, 2011
- FDA report date
- Sep 26, 2012
- Quantity
- 67,775 Applicators
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Carefusion 213, Llc
Original FDA data
Every field from FDA enforcement report D-1674-2012, exactly as published.
Show all FDA fields
- City
- El Paso
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 62971
- Address
- 1550 Northwestern Dr
- Code information
- Product code 260415, Lot#: 48225
- Postal code
- 79912-8000
- Report date
- Sep 26, 2012
- Product type
- Drugs
- Recall number
- D-1674-2012
- Classification
- Class II
- Recalling firm
- Carefusion 213, Llc
- Product quantity
- 67,775 Applicators
- Termination date
- May 23, 2013
- Reason for recall
- Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 8, 2011
- Initial firm notification
- Letter
- Center classification date
- Sep 17, 2012