The Recall Desk
SevereFDA (Drugs)·D-0835-2018·Announced 2018-05-30

Ideaz Recalls Screamin' Menthol Pain Gel Due to Benzene Levels

Ideaz Llc is recalling Screamin' Menthol Pain Relieving Gel because it contains benzene levels exceeding FDA limits.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves benzene, a known carcinogen, which aligns with the 'Severe' criteria for significant health risks.

Plain-English summary

Ideaz Llc is voluntarily recalling Screamin' Menthol (menthol) Pain Relieving Gel, 4%, in 2 oz, 5 oz, and 16 oz packages. The recall involves approximately 800 pounds of the product, which was distributed nationwide in the U.S.A.

The recall was initiated because the product was manufactured with an ingredient that exceeds the benzene levels allowed in drug products. This constitutes a deviation from Current Good Manufacturing Practices (CGMP). The affected lots are 1015019 (Exp 10/18) and 1116011 (Exp 11/19).

Consumers should check their products for the specific lot numbers and expiration dates listed above. If they possess the recalled product, they should stop using it and contact the recalling firm for instructions on return or disposal.

The recalled product

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 52099-801
Manufacturer
Ideaz Llc
Category
Drug — Topical Analgesic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: 1015019
  • Exp 10/18
  • 1116011
  • Exp 11/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Ideaz Llc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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Same hazard · benzene contamination

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