LOW RISK
Terminated
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
Recalled by Prolacta Bioscience
Classification
Class III — Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.
Reason for Recall
Shipped lot was un released and under quarantine pending investigation closures.
Product Details
Product Quantity
16 bottles (1 case with 4 individual bottles per carton)
Product Type
Food
Code Info
Lot: CC101806USA; Expiration: 11/19/20
Voluntary/Mandated
Voluntary: Firm initiated
Distribution & Geography
Distribution Pattern
One customer in NC
Company Location
Duarte, CA, 91010-2837
Timeline
Report Date
03/06/2019
Recall Initiated
01/29/2019
Classification Date
02/27/2019
Termination Date
03/04/2019
Source: U.S. Food & Drug Administration (FDA) — FDA Recalls
Last updated: July 13, 2026
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