The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0834-2018·Announced 2018-05-30

Ideaz Recalls Screamin' Hot Pain Gel Due to Benzene Levels

Ideaz LLC is recalling Screamin' Hot Pain Relieving Gel because it was manufactured with benzene levels exceeding FDA limits.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the presence of benzene above allowed levels in a drug product represents a significant health hazard, meeting the criteria for a Severe rating.

Plain-English summary

Ideaz LLC is recalling Screamin' Hot (capsaicin) Pain Relieving Gel, 0.03%, in 2 oz, 5 oz, and 16 oz containers. The recall affects approximately 820.125 pounds of product distributed nationwide in the U.S.A. The specific lots involved are 116002 (Exp 01/19), 217003 (Exp 02/20), and 1217017 (Exp 12/20).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products were manufactured with an ingredient that exceeded the benzene levels allowed in drug products. Benzene is a known carcinogen, and its presence above permitted limits poses a health risk to consumers.

Consumers who have purchased these specific lots of Screamin' Hot Pain Relieving Gel should stop using the product and contact Ideaz LLC or their point of purchase for a refund or replacement. The product was manufactured for Toast Products, located in Pittsburgh, PA.

The recalled product

Product
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…
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 (6)

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

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 →

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