REJUV ORIGINALS LOW CALORIE ORANGE DRINK MIX NATURAL FLAVOR, NET WT. 8.6 OZ.
DYMA BRANDS recalled this product and the FDA reported the enforcement action on 11 December 2024 as Class II. The recall was initiated by the firm. After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
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
REJUV ORIGINALS LOW CALORIE ORANGE DRINK MIX NATURAL FLAVOR, NET WT. 8.6 OZ. (244g), UPC 8 22486 14388 6, Case UPC 30822486143887, MARKETED BY INDEPENDENT MARKETING ALLIANCE HOUSTON, TX 77043
UPC
822486143886
Reason for recall
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Products were distributed to the following states: AR, AZ, CA, CO, CT, FL, GA, IA, IL, LA, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, OH, OK, OR, PA, TN, TX, UT, WA, WI & WV.
Initiated
2 October 2024
Reported by FDA
11 December 2024
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
50935: Lot 264 EGA
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 21 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 21 separate recalls, which almost every published figure does, overstates it by a factor of 21. 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 21 of them.
This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
The distribution pattern names 27 states, and the FDA published the enforcement report 2 months after the firm began the recall.
Juice is the other food with its own HACCP regulation in the United States, 21 CFR part 120, which requires a treatment achieving a 5-log reduction of the pertinent pathogen, and unpasteurised juice recalls are almost always a failure of that step or an exemption misapplied.
A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.
A preventive controls plan covers foreign material 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 117.40
Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
21 CFR 117.80(c)
Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
21 CFR 117.150
Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
Other beverages and juice 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.
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
21 CFR 117.40 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.
