Drug recall
screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b)…
FDA recall event 79967 · Class II · Ideaz Llc
Key facts
| Event ID | 79967 |
|---|---|
| Recall numbers | D-0834-2018, D-0835-2018 |
| Recalling firm | Ideaz Llc |
| Product type | Drugs |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products. |
| Initiation date | May 16, 2018 |
| Report date | May 30, 2018 |
| Termination date | Nov 6, 2018 |
| City | Mc Kees Rocks |
| State | PA |
| Country | United States |
| FEI number | 3008674360 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: