Why it was recalled
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Product description
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32
Lot numbers, UPCs & expiration codes
Lot #: 0065386 Exp. 2/28/2023; 0091666 Exp. 3/31/2023
Where it was sold
Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
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-1509-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 23, 2020
- FDA report date
- Aug 26, 2020
- Quantity
- 12,500 applicators
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CareFusion 213, LLC
Original FDA data
Every field from FDA enforcement report D-1509-2020, exactly as published.
Show all FDA fields
- City
- El Paso
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 85903
- Address
- 1550 Northwestern Dr
- Code information
- Lot #: 0065386 Exp. 2/28/2023; 0091666 Exp. 3/31/2023
- Postal code
- 79912-8000
- Report date
- Aug 26, 2020
- Product type
- Drugs
- Recall number
- D-1509-2020
- Classification
- Class I
- Recalling firm
- CareFusion 213, LLC
- Product quantity
- 12,500 applicators
- Termination date
- Sep 28, 2022
- Reason for recall
- Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32
- Distribution pattern
- Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
- Recall initiation date
- Jun 23, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 19, 2020