Home / Recalls / Ideaz Llc / D-0834-2018

D-0834-2018 Class II Terminated

Recalled by Ideaz Llc — Mc Kees Rocks, PA

Recall Details

Product Type: Drugs
Report Date: May 30, 2018
Initiation Date: May 16, 2018
Termination Date: November 6, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 820.125 pounds

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.

Reason for Recall

CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.

Distribution Pattern

Nationwide in the U.S.A.

Code Information

Lot #: 116002, Exp 01/19; 217003, Exp 02/20; 1217017, Exp 12/20