Live Well Kratom Green Maeng Da in 150 capsule and 300 capsule plastic bottles.
TRIANGLE PHARMANATURALS LLC recalled this product and the FDA reported the enforcement action on 16 May 2018 as Class I. The recall was mandated. All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with Salmonella
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
Live Well Kratom Green Maeng Da in 150 capsule and 300 capsule plastic bottles. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Reason for recall
All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with Salmonella
WA, GA, SC, FL, NJ, LA, CA, TX, NV, NC, PA, MO, CO, OR, MT, MA, UT, NE, AZ, MO, NY, OH, VA, MD.
Initiated
6 April 2018
Reported by FDA
16 May 2018
Terminated
26 March 2021
Firm notified by
Letter
Product codes
ALL
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.
This recall was not recorded as firm-initiated. The circumstances in which the FDA requests a recall are set out in 21 CFR 7.45.
This is one of 26 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 26 separate recalls, which almost every published figure does, overstates it by a factor of 26. 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 26 of them.
The recall ran for 3.0 years, from 6 April 2018 to termination on 26 March 2021. 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 6 weeks 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.
Salmonella is a bacterium that survives in low-moisture foods for months, which is why it appears in recalls of products that carry no water for it to grow in: nut butters, spices, flour and dry pet food.
A preventive controls plan covers Salmonella 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 117.165(a)(2)
Product testing: testing as a verification activity, appropriate to the facility, the food and the nature of the preventive control.
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.
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.
Recall 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.
