Drug recall
Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by…
FDA recall event 71401 · Class I · Centro Naturista
Key facts
| Event ID | 71401 |
|---|---|
| Recall numbers | D-0877-2016, D-0878-2016 |
| Recalling firm | Centro Naturista |
| Product type | Drugs |
| Products | Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011, Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein. |
| Initiation date | Jun 3, 2015 |
| Report date | Jun 1, 2016 |
| Termination date | Mar 30, 2017 |
| City | Dallas |
| State | TX |
| Country | United States |
| FEI number | 3011461901 |
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: