Drug product
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.
D-0834-2018
Product summary
- Firm
- Ideaz Llc
- Event
- Event 79967
- Status
- Terminated
- Classification
- Class II
- Quantity
- 820.125 pounds
- Official record key
drug-enforcement:D-0834-2018
Official wording
Reason: CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Code information: Lot #: 116002, Exp 01/19; 217003, Exp 02/20; 1217017, Exp 12/20
Distribution pattern: Nationwide in the U.S.A.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations