PlainRecalls
FDA Food Low Class III Terminated

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

Reported: March 6, 2019 Initiated: January 29, 2019 #F-1099-2019

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

Reason for Recall

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

Details

Recalling Firm
Prolacta Bioscience
Units Affected
16 bottles (1 case with 4 individual bottles per carton)
Distribution
One customer in NC
Location
Duarte, CA

Frequently Asked Questions

What product 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. Recalled by Prolacta Bioscience. Units affected: 16 bottles (1 case with 4 individual bottles per carton).
Why was this product recalled?
Shipped lot was un released and under quarantine pending investigation closures.
Which agency issued this recall?
This recall was issued by the FDA Food on March 6, 2019. Severity: Low. Recall number: F-1099-2019.