Class IIITerminated in FDA datasetRecall initiated Jan 29, 2019

Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code: 94000-10 4 - 10 mL…

Recalling firm: Prolacta Bioscience

Why it was recalled

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

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Mar 4, 2019.

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ProductProlact 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
Package size10 mL

FDA code information

Lot: CC101806USA; Expiration: 11/19/20

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Full FDA record and distribution details

Original product description

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

Extracted codes and context

TypeCode / valueContext
expiration11/19/20Lot: CC101806USA; Expiration: 11/19/20
lotCC101806USALot: CC101806USA; Expiration: 11/19/20

Original FDA recall reason

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

Recall details

Recall number
F-1099-2019
Event ID
82034
FDA status
Terminated
Initiated
Jan 29, 2019
Reported
Mar 6, 2019
Classified
Feb 27, 2019
Terminated
Mar 4, 2019
Quantity
16 bottles (1 case with 4 individual bottles per carton)
Location
Duarte, CA, United States
Initiation type
Voluntary: Firm initiated
Notification
E-Mail

Where it was distributed

One customer in NC

FDA source record · F-1099-2019

Data updated September 16, 2026. View official FDA data ↗

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