HyVee applesauce; 3.5 oz applesauce in aluminum pouch with plastic screw-on lid; product…
PUREFRUIT CHILE S.A recalled this product and the FDA reported the enforcement action on 6 August 2014 as Class II. The recall was initiated by the firm. Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold.
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
- HyVee applesauce; 3.5 oz applesauce in aluminum pouch with plastic screw-on lid; product is labeled in part, "***HyVee Mother's Choice Apple organic baby food NET WT 3.5 OZ (99g)***INGREDIENTS:ORGANIC APPLE, ASCORBIC ACID DISTRIBUTED BY HY-VEE, INC WEST DES MOINES, IA 50266 PRODUCT OF CHILE***" UPC Code: 075450082029
- Reason for recall
- Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold.
- Recalling firm
- PUREFRUIT CHILE S.A
- Firm location
- Curico, Chile
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-2232-2014
- Quantity
- Market Pantry (app+app cin) : 63,958 cases (48 pouches/case); Fruty U: 51,105 cases (40 pouches/case); Mother's Choice: 3132 cases (16 pouches/case).
- Distribution
- Product was manufactured and shipped from Chile and stored in Purefruit Chile warehouses located in Marlyland and California. Product was further distributed to retail stores nationwide.
- Initiated
- 1 July 2014
- Reported by FDA
- 6 August 2014
- Terminated
- 24 March 2015
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Best By: NOV 12 2014
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 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. 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 5 of them.
- The recall ran for 9 months, from 1 July 2014 to termination on 24 March 2015. 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 5 weeks after the firm began the recall.
- Recalls of infant formula or baby food run a median of 10 months, so this one was about typical for its category. Infant formula is the most tightly regulated food in the United States because it is frequently the only thing an infant eats, so a nutrient deviation is a hazard in a way it is not in any other product.
What this recall was for
Spoilage and mould
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.
Filed under infant formula and baby food and fresh produce. A product can sit in more than one.
Other infant formula and baby food 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 PUREFRUIT CHILE S.A
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
All 5 records for PUREFRUIT CHILE S.A
All 2014 recalls · All FDA food recall data
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.
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.