Gold Coast Health Vitality Men's Health Capsules 90ct Bottle NO UPC CODE
NutraCap Labs LLC recalled this product and the FDA reported the enforcement action on 19 January 2022 as Class I. The recall was initiated by the firm. During an FDA investigation the firm was notified that the product contains undeclared milk.
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
- Gold Coast Health Vitality Men's Health Capsules 90ct Bottle NO UPC CODE
- Reason for recall
- During an FDA investigation the firm was notified that the product contains undeclared milk.
- Recalling firm
- NutraCap Labs LLC
- Firm location
- Norcross, Georgia, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0443-2022
- Quantity
- 80,169 various bottles and jars
- Distribution
- Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MD, MN, NC, NJ, NV, NY, OH, OR, SC, TN, TX, VA & WA.
- Initiated
- 9 November 2021
- Reported by FDA
- 19 January 2022
- Terminated
- 21 May 2024
- Firm notified by
- Press Release
- Product codes
- LOT #2011187 EXP DATE 11/2022
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 106 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 106 separate recalls, which almost every published figure does, overstates it by a factor of 106. 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 106 of them.
- The recall ran for 2.5 years, from 9 November 2021 to termination on 21 May 2024. 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 distribution pattern names 23 states, and the FDA published the enforcement report 2 months after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was longer 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.
Named in the distribution pattern: Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, South Carolina, Tennessee, Texas. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
What this recall was for
Undeclared allergens
An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.
A preventive controls plan covers an undeclared allergen 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 117.135(c)(2)
- Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
- 21 CFR 101.4
- Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
- 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.
The allergens named in this record: milk.
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 NutraCap Labs LLC
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 105 other records name this firm.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2022-01-19 | BlakeFit Everyday All-in-one Lime Watermelon 44oz Jar UPC CODE X002J9E9KD 323359000058 | NutraCap Labs LLC | During an FDA investigation the firm was notified that the product contains undeclared milk. | Class I |
| 2022-01-19 | OTAK Innovations OTAK:AM Capsules 90ct Bottle UPC CODE 4 08012 0204 | NutraCap Labs LLC | During an FDA investigation the firm was notified that the product contains undeclared milk. | Class I |
| 2022-01-19 | Huge Nutrition Enhance Capsules 240ct Bottle UPC CODE 7 28614 77810 7 | NutraCap Labs LLC | During an FDA investigation the firm was notified that the product contains undeclared milk. | Class I |
| 2022-01-19 | Hi-T Level Up Capsules 120ct Bottle UPC CODE | NutraCap Labs LLC | During an FDA investigation the firm was notified that the product contains undeclared milk. | Class I |
| 2022-01-19 | TM Nutrition Restoration Pineapple 19oz Jar UPC CODE 0 746477 745166 | NutraCap Labs LLC | During an FDA investigation the firm was notified that the product contains undeclared milk. | Class I |
| 2022-01-19 | Healthy Habits GH3 Maxum Capsules 90ct Bottle UPC CODE | NutraCap Labs LLC | During an FDA investigation the firm was notified that the product contains undeclared shellfish. | Class I |
| 2022-01-19 | Greater Her Resilient Capsules 30ct Bottle NO UPC CODE | NutraCap Labs LLC | During an FDA investigation the firm was notified that the product contains undeclared milk. | Class I |
| 2022-01-19 | First Finisher/Ouro Vitae Mito Male Cherry Limeade 16oz Jar NO UPC CODE | NutraCap Labs LLC | During an FDA investigation the firm was notified that the product contains undeclared milk. | Class I |
| 2022-01-19 | BlakeFit Everyday Gold Raspberry Lemonade Sample NO BARCODE | NutraCap Labs LLC | During an FDA investigation the firm was notified that the product contains undeclared milk. | Class I |
| 2022-01-19 | Rare Planet Health Rise Multivitamin Capsules 60ct Bottle UPC CODE | NutraCap Labs LLC | During an FDA investigation the firm was notified that the product contains undeclared shellfish. | Class I |
All 106 records for NutraCap Labs LLC
All 2022 recalls · All FDA food recall data
21 CFR 117.135(c)(2) 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.