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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82034

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 29, 2019
Product types
Food
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Prolacta Bioscience

Dossier provenance

Source snapshots represented here

  • openFDA Food Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

food · product 1 of 1

Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code: 94000-10 4 - 10 mL (0.3 fl. oz) Bottles, Net 40 mL (1.2 fl.oz. Intended for premature/LBW Infants fed human milk. Ingredients: Human milk cream and human milk ultrafiltration permeate. Manufactured by: Prolacta Bioscience, Inc., City of Industry, CA 91746

F-1099-2019
Recall number
F-1099-2019
Initiated
January 29, 2019
Classification
Class III
Status
Terminated
Recalling firm
Prolacta Bioscience
Quantity
16 bottles (1 case with 4 individual bottles per carton)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Shipped lot was un released and under quarantine pending investigation closures.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Shipped lot was un released and under quarantine pending investigation closures.

Code information

Lot: CC101806USA; Expiration: 11/19/20

Distribution pattern

One customer in NC