Human breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade…
Mothers Milk Bank recalled this product and the FDA reported the enforcement action on 2 October 2013 as Class II. The recall was initiated by the firm. Human Breast milk was collected from a donor that tested reactive for Hepatitis B in a screening test.
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
- Human breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade Milk. Mother's Milk Bank 751 S. Bascom Abe.San Jose, CA 95128
- Reason for recall
- Human Breast milk was collected from a donor that tested reactive for Hepatitis B in a screening test.
- Recalling firm
- Mothers Milk Bank
- Firm location
- San Jose, California, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1949-2013
- Quantity
- 70 x 4 oz. bottles
- Distribution
- Product was distributed to 6 hospitals in Honolulu and California.
- Initiated
- 20 August 2013
- Reported by FDA
- 2 October 2013
- Terminated
- 26 September 2013
- Firm notified by
- Telephone
- Product codes
- Batch number SC1308067; 001-071, Expiry 2/2/14
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 5 weeks, from 20 August 2013 to termination on 26 September 2013. 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 6 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
Viral and parasitic contamination
Hepatitis A, norovirus and Cyclospora recalls trace back to a person or to water rather than to the process: an infected food handler, or produce irrigated or washed with contaminated water.
A preventive controls plan covers viral or parasitic contamination 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 117.10
- Personnel: the hygiene practices, and the exclusion of anyone with an illness or open lesion that could contaminate food, that a facility must require.
- 21 CFR 112
- Produce safety: the agricultural water, worker health and hygiene standards for farms growing produce eaten raw.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
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.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2022-07-27 | Revie Superfoods Coconut Cream 190g Ready-to-Blend Coconut Delight Smoothie Made in Canada UPC 8 54681 00016 9 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada | Revive Organics, Inc. | Potential norovirus from IQF raspberries that were used as an ingredient in the products. | Class II |
| 2020-07-22 | Fresh Express Farmer's Garden 9 oz., UPC 071279281025, Butter & red leaf lettuce, grape tomatoes, carrots & radishes | Fresh Express Incorporated | Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora. | Class II |
| 2017-03-29 | Ciao Bovina Italian Strawberry. 1 Pint (473 ml). Non-Dairy Gelato. No GMO's. Coconut Free. Soy Free. | Ciao Bovina, LLC | Ciao Bovina, LLC announces a voluntary field action for Italian Strawberry Gelato due to potential contamination with Hepatitis A Virus. | Class I |
| 2017-03-29 | Strawberry Cream gelato, 5 Liter & 4 Liter pans | Leo Leo Gelato | Leo Leo Gelato is recalling gelato and sorbetto because they contain frozen strawberries that may be contaminated with hepatitis A virus. | Class I |
| 2017-03-29 | Boulder Ice Cream Strawberry. 2.5 gallon tub with white top. Keep frozen at -20F. | Altamira Specialty Food Service | Altamira Specialty Food Service announces a voluntary field action for Strawberry Ice Cream after receiving notice from its supplier that the strawberries used in the product may be contaminated with Hepatitis A virus. | Class I |
All 2013 recalls · All FDA food recall data
21 CFR 117.10 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.