Drug product
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
D-004-2013
Product summary
- Event
- Event 62900
- Status
- Terminated
- Classification
- Class II
- Quantity
- 576 Cartons
- Official record key
drug-enforcement:D-004-2013
Official wording
Reason: Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Code information: Lot 52894, Product Code: 260400
Distribution pattern: IL, MO, and NJ
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility