Class IIIFDA29 Jan 2019F-1099-2019

Prolacta Bioscience recalls Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code: 94000-10 4 - (Class III)

Class III — Eating this product is not likely to cause health problems, but it violates FDA labelling or manufacturing rules.

Product

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.

Affected products (1)

Recall #	Product	Lot / code	Status
F-1099-2019	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	Lot: CC101806USA; Expiration: 11/19/20	Terminated

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