PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: May 30, 2018 Initiated: May 16, 2018 #D-0835-2018

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.

Details

Recalling Firm
Ideaz Llc
Units Affected
800 pounds
Distribution
Nationwide in the U.S.A.
Location
Mc Kees Rocks, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Ideaz Llc. Units affected: 800 pounds.
Why was this product recalled?
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 30, 2018. Severity: Moderate. Recall number: D-0835-2018.