Why it was recalled
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Product description
screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8005.
Lot numbers, UPCs & expiration codes
Lot #: 116002, Exp 01/19; 217003, Exp 02/20; 1217017, Exp 12/20
Where it was sold
Nationwide in the U.S.A.
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-0834-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 16, 2018
- FDA report date
- May 30, 2018
- Quantity
- 820.125 pounds
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ideaz Llc
Original FDA data
Every field from FDA enforcement report D-0834-2018, exactly as published.
Show all FDA fields
- City
- Mc Kees Rocks
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 79967
- Address
- 400 Sproul St
- Code information
- Lot #: 116002, Exp 01/19; 217003, Exp 02/20; 1217017, Exp 12/20
- Postal code
- 15136-2811
- Report date
- May 30, 2018
- Product type
- Drugs
- Recall number
- D-0834-2018
- Classification
- Class II
- Recalling firm
- Ideaz Llc
- Product quantity
- 820.125 pounds
- Termination date
- Nov 6, 2018
- Reason for recall
- CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8005.
- Distribution pattern
- Nationwide in the U.S.A.
- Recall initiation date
- May 16, 2018
- Initial firm notification
- Letter
- Center classification date
- May 24, 2018