Why it was recalled
cGMP violations noted during the firm's most recent inspection.
Product description
SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304
Lot numbers, UPCs & expiration codes
Lot # 170626, EXP 6/26/2019; and 180131, EXP 01/31/2020
Where it was sold
Nationwide in the US
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-0291-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 16, 2018
- FDA report date
- Dec 19, 2018
- Quantity
- 71 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CAO Group, Inc.
Original FDA data
Every field from FDA enforcement report D-0291-2019, exactly as published.
Show all FDA fields
- City
- West Jordan
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 81556
- Address
- 4628 W Skyhawk Dr
- Code information
- Lot # 170626, EXP 6/26/2019; and 180131, EXP 01/31/2020
- Postal code
- 84084-4501
- Report date
- Dec 19, 2018
- Product type
- Drugs
- Recall number
- D-0291-2019
- Classification
- Class II
- Recalling firm
- CAO Group, Inc.
- Product quantity
- 71 cartons
- Termination date
- Feb 27, 2020
- Reason for recall
- cGMP violations noted during the firm's most recent inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Nov 16, 2018
- Initial firm notification
- Letter
- Center classification date
- Dec 11, 2018