GnuPharma Stress 100% Herbal Supplement 60 Capsules
GnuPharma Corp. recalled this product and the FDA reported the enforcement action on 26 July 2017 as Class II. The recall was initiated by the firm. 1 ingredient failed identity testing and 2 ingredients failed microbiological testing (E.coli)
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
- GnuPharma Stress 100% Herbal Supplement 60 Capsules
- Reason for recall
- 1 ingredient failed identity testing and 2 ingredients failed microbiological testing (E.coli)
- Recalling firm
- GnuPharma Corp.
- Firm location
- Owasso, Oklahoma, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0299-2017
- Quantity
- 131 bottles
- Distribution
- US
- Initiated
- 8 May 2017
- Reported by FDA
- 26 July 2017
- Terminated
- 15 November 2018
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- products manufactured prior to May 8th, 2017.
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 6 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 6 separate recalls, which almost every published figure does, overstates it by a factor of 6. 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 6 of them.
- The recall ran for 18 months, from 8 May 2017 to termination on 15 November 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 3 months after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was about typical 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
E. coli
Shiga toxin-producing E. coli recalls concentrate in foods eaten raw or lightly cooked, where no step in the process is hot enough or long enough to be a kill step.
A preventive controls plan covers E. coli contamination 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)(1)
- Process controls: the controls that apply a treatment, such as a validated kill step, at the point where it reduces the hazard to a safe level.
- 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.
- 21 CFR 120
- Juice HACCP: the hazard analysis and critical control point system required for juice processors, including a treatment achieving a 5-log pathogen reduction.
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 GnuPharma Corp.
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 |
|---|---|---|---|---|
| 2017-07-26 | GnuPharma ECS Herbal Tea Relief SAMPLE ONLY | GnuPharma Corp. | 1 ingredient failed identity testing and 2 ingredients failed microbiological testing (E.coli) | Class II |
| 2017-07-26 | GnuPharma Foundation 100% Herbal Supplement 60 Capsules | GnuPharma Corp. | 1 ingredient failed identity testing and 2 ingredients failed microbiological testing (E.coli) | Class II |
| 2017-07-26 | GnuPharma Fit 100% Herbal Supplement 60 Capsules | GnuPharma Corp. | 1 ingredient failed identity testing and 2 ingredients failed microbiological testing (E.coli) | Class II |
| 2017-07-26 | GnuPharma Sleep 100% Herbal Supplement 60 Capsules | GnuPharma Corp. | 1 ingredient failed identity testing and 2 ingredients failed microbiological testing (E.coli) | Class II |
| 2017-07-26 | GnuPharma Relief 100% Herbal Supplement 60 Capsules | GnuPharma Corp. | 1 ingredient failed identity testing and 2 ingredients failed microbiological testing (E.coli) | Class II |
All 6 records for GnuPharma Corp.
All 2017 recalls · All FDA food recall data
21 CFR 117.135(c)(1) 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.