Parent's Choice Advantage Infant Formula Milk-Based Powder with Iron, 35 oz, 922 g, with…
Perrigo Company PLC recalled this product and the FDA reported the enforcement action on 24 July 2019 as Class II. The recall was mandated. Product may contain metal fragments.
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
- Parent's Choice Advantage Infant Formula Milk-Based Powder with Iron, 35 oz, 922 g, with UPC: 078742022468
- UPC
- 078742022468
- Reason for recall
- Product may contain metal fragments.
- Recalling firm
- Perrigo Company PLC
- Firm location
- Allegan, Michigan, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1558-2019
- Quantity
- 23,388 containers
- Distribution
- Walmart, nationwide
- Initiated
- 20 June 2019
- Reported by FDA
- 24 July 2019
- Terminated
- 30 October 2019
- Firm notified by
- Letter
- Product codes
- Lot Code C26EVFV with a use by date of February 26, 2021
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.
- This recall was not recorded as firm-initiated. The circumstances in which the FDA requests a recall 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 4 months, from 20 June 2019 to termination on 30 October 2019. 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 shorter 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.
What this recall was for
Foreign material
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.
Filed under infant formula and baby food and milk and dairy. 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.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2022-07-20 | Nature s Promise Organic Mango, Banana, Kale, Rice & Pineapple Baby Food, 3.5 oz (99 g), Pouch, Case pack of 12 (12 inners of 6 each). Store in a dry ventilated area. Do not expose to sunlight. Do not microwave. After opening, store in refrigerator a maximum of 48 hours. Shake well before opening. | Fruselva America SPA | Elevated levels of thallium (heavy metal) | Class II |
| 2019-02-20 | Parent's Choice Toddler Next Stage¿ Milk Drink Powder Natural Milk Flavor With Other Natural Flavors, Stage 3, 1 Year and Up, NET WT 24 OZ (1.5 LB) 680g, UPC: 0 78742 06717 9 and Little JOURNEY Toddler Next Stage MILK DRINK POWDER, NET WT I PESO NETO 24 OZ I ONZAS (1.5 LB) 680g. | PBM Nutritionals, LLC | Product may contain foreign material. | Class II |
Other records from Perrigo Company PLC
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2019-03-20 | Simple Truth Organic Banana, Strawberry & Apple Fruit Puree with Nonfat Greek Yogurt, 113 g, packed in a laminate pouch, Each case has 6 cartons with 6 pouches per carton. Total of 36 pouches per case. | Perrigo Company PLC | Perrigo Company is initiating a voluntary recall of one production lot of Simple Truth Organic Banana, Strawberry and Apple Fruit Puree with Nonfat Greek Yogurt, LOT L8159, best by 08/06/2019 due to improper labeling that does not indicate the presence of milk. | Class II |
All 2019 recalls · All FDA food recall data
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.
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.