Energique, Dietary Supplement, Enervimin CNCR Focus, Dist. by Energique Inc..
Grato Holdings, Inc. recalled this product and the FDA reported the enforcement action on 16 May 2018 as Class II. The recall was initiated by the firm. Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Energique, Dietary Supplement, Enervimin CNCR Focus, Dist. by Energique Inc.. Woodbine, IA 51579
- Reason for recall
- Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
- Recalling firm
- Grato Holdings, Inc.
- Firm location
- Woodbine, Iowa, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1403-2018
- Quantity
- 767 120-tablet bottles
- Distribution
- Shipped to customers nationwide and Canada.
- Initiated
- 16 April 2018
- Reported by FDA
- 16 May 2018
- Terminated
- 17 August 2018
- Firm notified by
- Letter
- Product codes
- 50070340, 55837004
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This is one of 4 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 4 separate recalls, which almost every published figure does, overstates it by a factor of 4. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 4 of them.
- The recall ran for 4 months, from 16 April 2018 to termination on 17 August 2018. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 4 weeks after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
What this recall was for
Unapproved ingredients
An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.
A preventive controls plan covers an unapproved ingredient under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 111
- Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
Filed under dietary supplements. A product can sit in more than one.
Other dietary supplements recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Grato Holdings, Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2024-07-10 | Energique Mineral Magic Dietary Supplement, 2 fl. oz (59 ml) bottle. | Grato Holdings, Inc. | Potential microbial contamination (yeast and/or mold). | Class II |
| 2024-07-10 | BioActive Nutritional MINAPLEX, Botanical Herbal Supplement; 1 Fl. oz. (30 ml) bottle. | Grato Holdings, Inc. | Potential microbial contamination (yeast and/or mold). | Class II |
| 2018-05-16 | Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579 | Grato Holdings, Inc. | Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. | Class II |
| 2018-05-16 | Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579 | Grato Holdings, Inc. | Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. | Class II |
| 2018-05-16 | Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579 | Grato Holdings, Inc. | Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. | Class II |
All 6 records for Grato Holdings, Inc.
All 2018 recalls · All FDA food recall data
21 CFR 111 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.