Drug product
screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8010.
D-0835-2018
Product summary
- Firm
- Ideaz Llc
- Event
- Event 79967
- Status
- Terminated
- Classification
- Class II
- Quantity
- 800 pounds
- Official record key
drug-enforcement:D-0835-2018
Official wording
Reason: CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Code information: Lot #: 1015019, Exp 10/18; 1116011, Exp 11/19
Distribution pattern: Nationwide in the U.S.A.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations