Prolacta Bioscience Recalls Unreleased Human Milk Caloric Fortifier Lot
Prolacta Bioscience is recalling a specific lot of human milk caloric fortifier that was under quarantine and not released for distribution.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The source text indicates the product was under quarantine and not released, with no reported illnesses or specific hazards named.
Plain-English summary
Prolacta Bioscience is recalling a specific lot of Prolact CR Human Milk Caloric Fortifier. The product is intended for premature or low-birth-weight infants fed human milk. The recalled lot is identified by the code CC101806USA and has an expiration date of 11/19/20.
The recall was initiated because the shipped lot was not released and was under quarantine pending the closure of an investigation. The source text does not specify the nature of the investigation or any specific safety hazards.
The distribution pattern is listed as one customer in North Carolina. Consumers should check their inventory for this specific lot number and expiration date. If the product is found, it should not be used.
The recalled product
- 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.…
- Manufacturer
- Prolacta Bioscience
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: CC101806USA
- Expiration: 11/19/20
Distribution
Distributed in 1 state:
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