Frozen Pasteurized Human Milk in glass bottles. Label contains lot code followed by…
Mothers' Milk Bank of Montana recalled this product and the FDA reported the enforcement action on 15 October 2014 as Class III. The recall was initiated by the firm. 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.
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
- 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
- Reason for recall
- 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.
- Recalling firm
- Mothers' Milk Bank of Montana
- Firm location
- Missoula, Montana, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-0016-2015
- Quantity
- 12 - 4oz bottles
- Distribution
- 354oz bottle of unpasteurized milk was transfered to Mother's Milk of San Jose, CA. 12 - 4oz bottles was delivered to Community Medical Center, Missoula, Montana.
- Initiated
- 13 May 2014
- Reported by FDA
- 15 October 2014
- Terminated
- 8 October 2014
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- MMBMT-050114-71-1 through MMBMT-050114-71-12. 050114 represents the date the milk was pasteurized; 71 refers to the batch number; 1 refers to the bottle number. A total of 46 bottles were pasteurized for batch 71.
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 is one of 2 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 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. All 2 of them are listed on this page.
- The recall ran for 5 months, from 13 May 2014 to termination on 8 October 2014. 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 months 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.
Filed under milk and dairy. A product can sit in more than one.
Every product in this recall
The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 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.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 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 |
Other milk and dairy recalls
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.
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 |
|---|---|---|---|---|
| 2015-06-17 | 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. | Mothers' Milk Bank of Montana | Mother's milk from batch #294 was recalled due to finding of plastic fragment in one bottle | 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 2014 recalls · All FDA food recall data
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.
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.