Drug recall
ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix…
FDA recall event 70661 · Class I · Ultra ZX Supplements
Key facts
| Event ID | 70661 |
|---|---|
| Recall numbers | D-0991-2015 |
| Recalling firm | Ultra ZX Supplements |
| Product type | Drugs |
| Products | ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein |
| Initiation date | Mar 10, 2015 |
| Report date | May 13, 2015 |
| Termination date | Apr 26, 2018 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 3011169160 |
At a glance
- 1–9 Products in this recall
- 1–9 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: