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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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