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.
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 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 52099-80
- Manufacturer
- Ideaz Llc
- Category
- Drug — Topical Analgesic
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 →Related recalls
Same manufacturer · Ideaz Llc
See all →- SevereIdeaz Recalls Screamin' Menthol Pain Gel Due to Benzene Levels
FDA (Drugs) · 2018-05-30
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