Mother's Milk was labeled as "Mature milk". This is breast milk and was donated from…
Mothers' Milk Bank of Montana recalled this product and the FDA reported the enforcement action on 17 June 2015 as Class III. The recall was initiated by the firm. Mother's milk from batch #294 was recalled due to finding of plastic fragment in one bottle
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
- Mother's Milk was labeled as "Mature milk". This is breast milk and was donated from nursing mothers. Product is packaged in glass bottle, 4 oz. The logo of Mother's Milk Bank is observed on a label. All milk was shipped frozen.
- Reason for recall
- Mother's milk from batch #294 was recalled due to finding of plastic fragment in one bottle
- Recalling firm
- Mothers' Milk Bank of Montana
- Firm location
- Missoula, Montana, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-2419-2015
- Quantity
- 63 bottles
- Distribution
- distributed in Montana and Washington.
- Initiated
- 24 April 2015
- Reported by FDA
- 17 June 2015
- Terminated
- 9 June 2015
- Firm notified by
- Telephone
- Product codes
- MMBMT-032815-294-39. Expiration date 10/1/15
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 7 weeks, from 24 April 2015 to termination on 9 June 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 8 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.
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 milk and dairy. A product can sit in more than one.
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.
Other records from Mothers' Milk Bank of Montana
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2014-10-15 | Frozen Pasteurized Human Milk in glass bottles. Label contains lot code followed by expiration date (month day year) and the description of the product which states Mature Milk. There is a Mothers' Milk Bank logo | Mothers' Milk Bank of Montana | Donor answered NO to question #32 "In the last 28 days, have you ever had a vaccine for measles, mumps or rubella?" It was later discovered that she had in fact received live vaccines for influenza, DTAP and MMR after delivery. | Class III |
| 2014-10-15 | Frozen Unpasteurized Human Milk in glass bottle. No labeling provided | Mothers' Milk Bank of Montana | Donor answered NO to question #32 "In the last 28 days, have you ever had a vaccine for measles, mumps or rubella?" It was later discovered that she had in fact received live vaccines for influenza, DTAP and MMR after delivery. | Class III |
All 3 records for Mothers' Milk Bank of Montana
All 2015 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.