Why it was recalled
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
Product description
ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
Lot numbers, UPCs & expiration codes
Lot 7096622, exp 3/21/2020
Where it was sold
IL, MO, PA, TN, & VA
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-0029-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 15, 2017
- FDA report date
- Nov 1, 2017
- Quantity
- 628,000 applicators
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Becton Dickinson & Company
Original FDA data
Every field from FDA enforcement report D-0029-2018, exactly as published.
Show all FDA fields
- City
- Franklin Lakes
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78124
- Address
- 1 Becton Dr
- Code information
- Lot 7096622, exp 3/21/2020
- Postal code
- 07417-1815
- Report date
- Nov 1, 2017
- Product type
- Drugs
- Recall number
- D-0029-2018
- Classification
- Class II
- Recalling firm
- Becton Dickinson & Company
- Product quantity
- 628,000 applicators
- Termination date
- Jun 27, 2018
- Reason for recall
- Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
- Distribution pattern
- IL, MO, PA, TN, & VA
- Recall initiation date
- Sep 15, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 23, 2017