3CS ORGANICS LLC recalled this product and the FDA reported the enforcement action on 19 July 2017 as Class II. The recall was initiated by the firm. The product is not FDA approved and not all products are labeled in English.
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
HIPP Tetrapack-Liquid , Single Serve Combiotik Hungry Infant, 200mL (6pk/24cases), HIPP Tetrapak-Liquid, Single Serve Combiotik First Infant Milk, 200mL (6pk/case)
Reason for recall
The product is not FDA approved and not all products are labeled in English.
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 9 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 9 separate recalls, which almost every published figure does, overstates it by a factor of 9. 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 9 of them.
The recall ran for 4.2 years, from 18 May 2017 to termination on 11 August 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 FDA published the enforcement report 2 months after the firm began the recall.
Recalls of infant formula or baby food run a median of 10 months, so this one was longer than usual 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.
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.
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.
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.
