Why it was recalled
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Product description
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83484 71794 3 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
Lot numbers, UPCs & expiration codes
Lots: 19277K2, 19278K1
Where it was sold
Nationwide in the USA
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-0786-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 20, 2019
- FDA report date
- Jan 15, 2020
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Idelle Labs
Original FDA data
Every field from FDA enforcement report D-0786-2020, exactly as published.
Show all FDA fields
- City
- El Paso
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 84620
- Address
- One Helen Of Troy Plaza
- Code information
- Lots: 19277K2, 19278K1
- Postal code
- 79912
- Report date
- Jan 15, 2020
- Product type
- Drugs
- Recall number
- D-0786-2020
- Classification
- Class III
- Recalling firm
- Idelle Labs
- Product quantity
- Unknown
- Termination date
- Sep 28, 2022
- Reason for recall
- Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83484 71794 3 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 20, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 16, 2020