FDA recall F-1099-2019

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.

Distribution

One customer in NC

Key facts

Status

Terminated

Initiation date

2019-01-29

Report date

2019-03-06

Termination date

2019-03-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Duarte, CA, United States

Primary source

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