Prolacta Bioscience recalls Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code: 94000-10 4 - 10 mL (0.3 fl. oz) Bottles, N…

Recall date

January 29, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

F-1099-2019

FDA classification

Class III

Brand / firm

Prolacta Bioscience

Sold / distributed

One customer in NC

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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