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
Reported: March 6, 2019 Initiated: January 29, 2019 #F-1099-2019
Product Description
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.
Details
- Recalling Firm
- Prolacta Bioscience
- Units Affected
- 16 bottles (1 case with 4 individual bottles per carton)
- Distribution
- One customer in NC
- Location
- Duarte, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Prolacta Bioscience. Units affected: 16 bottles (1 case with 4 individual bottles per carton).
Why was this product recalled? ▼
Shipped lot was un released and under quarantine pending investigation closures.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on March 6, 2019. Severity: Low. Recall number: F-1099-2019.
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