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Recall Observatory FDA recall evidence

Derived label

Unknown

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.no_named_rule

v1.0.0

Assignment summary

Mode key
unknown
Evidence excerpt
Shipped lot was un released and under quarantine pending investigation closures.
Rule explanation
A recall reason is available, but none of the published named rules supports a failure-mode interpretation.
Firm
Prolacta Bioscience

Field note

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