Drug product
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
D-1442-2014
Product summary
- Event
- Event 68566
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,000 Applicators
- Official record key
drug-enforcement:D-1442-2014
Official wording
Reason: Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Code information: Lot #: 71132, Expiry: 02/2017
Distribution pattern: Nationwide in U.S.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility