Drug product
Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, St. Louis, MO 63133, Reorder # 1452-RF, NDC 0519-1452-13, UPC (01)00724995 086251.
D-0518-2016
Product summary
- Firm
- Steris Corp
- Event
- Event 72479
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 cases - 54 bottles
- Official record key
drug-enforcement:D-0518-2016
Official wording
Reason: Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.
Code information: Lot # 277120, Exp 06/01/17
Distribution pattern: Medical Center/Hospitals in FL, MO, and TN.
Derived failure modes
-
Labeling or packaging
Labeling: Not Elsewhere Classified; Incorrect