Recall Enforment Report D-0834-2018
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Ideaz Llc, originally initiated on 05-16-2018 for the 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. The product was recalled due to cgmp deviations: products manufactured with an ingredient that exceed the benzene levels allowed in drug products.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0834-2018 | 05-16-2018 | 05-30-2018 | Class II | 820.125 pounds | 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. | CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products. | Terminated |
| D-0835-2018 | 05-16-2018 | 05-30-2018 | Class II | 800 pounds | 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. | CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products. | Terminated |
