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Recall Observatory FDA recall evidence

Food 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

F-1099-2019

January 29, 2019

Class III

Product summary

Firm
Prolacta Bioscience
Event
Event 82034
Status
Terminated
Classification
Class III
Quantity
16 bottles (1 case with 4 individual bottles per carton)
Official record key
food-enforcement:F-1099-2019

Official wording

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

Code information: Lot: CC101806USA; Expiration: 11/19/20

Distribution pattern: One customer in NC

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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