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Prolacta Bioscience
FDA recall F-1099-2019 · Class III · reported 2019-03-06 · Terminated
- 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
- Shipped lot was un released and under quarantine pending investigation closures.
- Quantity
- 16 bottles (1 case with 4 individual bottles per carton)
- Distribution
- One customer in NC
- Firm location
- CA, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Recall started
- 2019-01-29
- Terminated
- 2019-03-04
- Code info
- Lot: CC101806USA; Expiration: 11/19/20
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.