MR. HYDE INTENSE ENERGY PRE WORKOUT, Green Apple Natural and Artificial Flavor Dietary…
ProSupps USA LLC recalled this product and the FDA reported the enforcement action on 8 April 2015 as Class II. The recall was initiated by the firm. The product contains more yohimbine hcl than declared on the label
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
- MR. HYDE INTENSE ENERGY PRE WORKOUT, Green Apple Natural and Artificial Flavor Dietary Supplement Net Weight 8.0 OZ (228 grams)
- Reason for recall
- The product contains more yohimbine hcl than declared on the label
- Recalling firm
- ProSupps USA LLC
- Firm location
- Allen, Texas, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1783-2015
- Quantity
- 944 units
- Distribution
- TX, NC, CA, OH, CT, FL, GA, IN
- Initiated
- 13 February 2015
- Reported by FDA
- 8 April 2015
- Terminated
- 4 February 2016
- Firm notified by
- Letter
- Product codes
- UPC: 682055405483, Lot # 0116L1 and 0117L1
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 12 months, from 13 February 2015 to termination on 4 February 2016. 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 8 states, and the FDA published the enforcement report 8 weeks after the firm began the recall.
- Recalls of fresh produce run a median of 7 months, so this one was longer than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.
Named in the distribution pattern: Texas, North Carolina, California, Ohio, Connecticut, Florida, Georgia, Indiana. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
Filed under fresh produce and dietary supplements. A product can sit in more than one.
Other fresh produce recalls
These are the closest records in the corpus: the same kind of food. 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 ProSupps USA LLC
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 31 other records name this firm.
All 32 records for ProSupps USA LLC
All 2015 recalls · All FDA food recall data
Behind every recall is a clause 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.