Drug product
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
D-1674-2012
Product summary
- Event
- Event 62971
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67,775 Applicators
- Official record key
drug-enforcement:D-1674-2012
Official wording
Reason: Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Code information: Product code 260415, Lot#: 48225
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility