Home / Recalls / Ideaz Llc / D-0835-2018

D-0835-2018 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: 800 pounds

Product Description

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.

Distribution Pattern

Nationwide in the U.S.A.

Code Information

Lot #: 1015019, Exp 10/18; 1116011, Exp 11/19