Carefusion 213, Llc: Bd Purprep, Povidone-iodine 8.3% W/w (0.83% Available Iodine) With Isopropyl Alcohol 72.5% W/w Sterile Solution, 25x26ml Applicators Per Carton. Ca...
Recall Summary CareFusion 213, LLC is recalling BD PurPrep antiseptic applicators (povidone-iodine 8.3% with isopropyl alcohol 72.5%, 25-pack cartons) distributed nationwide because the company cannot guarantee the product is sterile and there is potential contamination. This is a Class II recall affecting product with NDC number 54365-014-42 manufactured in El Paso, Texas.
- Recalling firm
- CareFusion 213, LLC
- Product
- BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
- Reason
- Lack of assurance of Sterility: potential product contamination
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-22
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/aa4a477f-cf27-434f-9372-ac465aa23c6e