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.
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 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…
- 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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