Why it was recalled
Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # 277120, Exp 06/01/17
Where it was sold
Medical Center/Hospitals in FL, MO, and TN.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0518-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 27, 2015
- FDA report date
- Dec 16, 2015
- Quantity
- 3 cases - 54 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Steris Corp
Original FDA data
Every field from FDA enforcement report D-0518-2016, exactly as published.
Show all FDA fields
- City
- Saint Louis
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 72479
- Address
- 7501 Page Ave
- Code information
- Lot # 277120, Exp 06/01/17
- Postal code
- 63133-1031
- Report date
- Dec 16, 2015
- Product type
- Drugs
- Recall number
- D-0518-2016
- Classification
- Class II
- Recalling firm
- Steris Corp
- Product quantity
- 3 cases - 54 bottles
- Termination date
- Jul 7, 2016
- Reason for recall
- Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Medical Center/Hospitals in FL, MO, and TN.
- Recall initiation date
- Oct 27, 2015
- Initial firm notification
- Letter
- Center classification date
- Dec 4, 2015