Plum Inc recalled this product and the FDA reported the enforcement action on 28 August 2013 as Class II. The recall was initiated by the firm. Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .
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
Plum Organics Mighty 4 Essential nutrition blend; Sweet Potato Blueberry Millet , Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003416; Case USPC:00846675003539 Distributed by Plum Inc., Emeryville, CA.
Reason for recall
Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .
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 5 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 5 separate recalls, which almost every published figure does, overstates it by a factor of 5. All 5 of them are listed on this page.
The recall ran for 2 months, from 19 July 2013 to termination on 30 September 2013. 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 6 weeks after the firm began the recall.
Recalls of milk or a dairy product run a median of 7 months, so this one was shorter than usual for its category. Dairy recalls split between pathogen contamination in products that skipped or under-ran pasteurisation and undeclared milk in products that should never have contained it, which is the same allergen viewed from two directions.
A spoilage recall means the food degraded before its date: mould growth, unintended fermentation, swelling or rancidity, usually traced to a seal, a formulation or a storage temperature.
A preventive controls plan covers spoilage 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 117.93
Warehousing and distribution: storage and transport under conditions that protect food against contamination and against deterioration of the food and its container.
21 CFR 117.80(b)(3)
Time and temperature: holding food at temperatures that do not allow microorganisms to grow, and for no longer than the process allows.
A process deviation recall means the process ran outside its validated limits: a thermal process that did not reach its time and temperature, a pH that drifted, or a seal that failed.
A preventive controls plan covers a process deviation 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 113
Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
21 CFR 114
Acidified foods: the controls on equilibrium pH at or below 4.6, and the process that achieves it.
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.
The FDA opened 5 enforcement records for this one recall, one per product code. This page carries all of them; the 4 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
Intermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .
Class II
Other milk and dairy 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.
Intermittent damage to the plastic spouts during manufacturing of two varieties of Plum products on two production dates may cause plastic fragments to break loose and cause a potential choking hazard.
Intermittent damage to the plastic spouts during manufacturing of two varieties of Plum products on two product dates may cause plastic fragments to break loose and cause a potential choking hazard.
21 CFR 117.93 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.
