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 per

FDA recall notice · announced March 6, 2019 · Prolacta Bioscience

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: One customer in NC
Lot/code information: Lot: CC101806USA; Expiration: 11/19/20
Quantity: 16 bottles (1 case with 4 individual bottles per carton)
Status: Terminated
Products in this recall event:
- 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. Ingredien (F-1099-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.