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.
Reason for recall: CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Recall initiated: 20180516
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated