Drug recall
OFF CYCLE II HARDCORE Capsules Dietary Supplement, 3,17-keto-etiochol-triene 25mg and…
FDA recall event 56743 · Class I · Fizogen Precision Technologies, Inc.
Key facts
| Event ID | 56743 |
|---|---|
| Recall numbers | D-119-2011 |
| Recalling firm | Fizogen Precision Technologies, Inc. |
| Product type | Drugs |
| Products | OFF CYCLE II HARDCORE Capsules Dietary Supplement, 3,17-keto-etiochol-triene 25mg and 3,5,7-Trihydroxy-4-methoxy-flavone 5mg, 90 count bottles, UPC 8 76436 00064 4, Developed/Manufactured exclusively… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed without an approved NDA/ANDA; product contains "ATD" an Aromatase Inhibitor marketed as a dietary supplement. |
| Initiation date | Sep 16, 2010 |
| Termination date | Apr 19, 2012 |
| City | Wellington |
| State | FL |
| Country | United States |
| FEI number | 2000007566 |
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