Drug recall: EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227…
Class I FDA enforcement event 70444. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
The recalling firm started this drug recall on 25 Jan 2015. The FDA record names a person as the firm, and this site does not show the name. The firm address in the FDA record is in Garner, NC. FDA put the recall in Class I. FDA event 70444 has 5 product records. The first FDA enforcement report date is 13 May 2015. The record gives the status Terminated, with the termination date 23 Jan 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
WV who distributed Nationwide.
Recalling firm
The name is withheld, Garner, NC.
The FDA record gives the name of a person as the recalling firm. This site does not show the names of persons.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0977-2015 | EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4. | 150 bottles | Class I | Terminated | 13 May 2015 |
| D-0978-2015 | iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4. | 175 bottles | Class I | Terminated | 13 May 2015 |
| D-0979-2015 | AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00418 1. | 150 bottles | Class I | Terminated | 13 May 2015 |
| D-0980-2015 | BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00406 8. | 173 bottles | Class I | Terminated | 13 May 2015 |
| D-0981-2015 | iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2. | 200 bottles | Class I | Terminated | 13 May 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2015
- 292
- Share of these events in Class I
- 17%
- Product records in this event
- 5
Official channels
- FDA enforcement report D-0977-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 70444. https://recallregister.com/fda/i/70444/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
WV who distributed Nationwide.
- What quantity of product is in FDA event 70444?
- The event has 5 product records. The first record gives this quantity:
150 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2015 have the same class?
- 17% of the 292 drug events that started in 2015 are in Class I.