FDA-Food2019-03-06Class III

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

Prolacta Bioscience
Hazard

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

Sold states
One customer in NC
Affected count
16 bottles (1 case with 4 individual bottles per carton)
Manufactured in
1800 Highland Ave, Duarte, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1099-2019

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