Prolacta Bioscience recalls Prolact CR: label issue
Find the official FDA enforcement report
Recall at a glance
- Recalling company
- Prolacta Bioscience
- Location
- Duarte, CA
- Reported by FDA
- March 6, 2019
- Recall started
- January 29, 2019
- Risk class
- Class III
- Status (latest data we have)
- Terminated
- Type
- Voluntary: Firm initiated
- Category
- Dairy and eggs
- Reason type
- Labeling and quality
Is my product affected?
Compare your product’s name, size and lot or date codes with the list below. A recall usually covers only specific codes.
- 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
Quantity: 16 bottles (1 case with 4 individual bottles per carton)
Codes: Lot: CC101806USA; Expiration: 11/19/20
Where it was distributed
One customer in NC
What to do
If you have this product, check the codes above. FDA recall notices often tell consumers to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information, and if you are unsure, do not eat it. If someone becomes ill after eating a recalled food, contact a healthcare professional. See FDA’s recalls and safety alerts for company announcements.
Frequently asked questions
What was recalled?
Prolacta Bioscience recalled 1 product, including 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….
Why was it recalled?
Shipped lot was un released and under quarantine pending investigation closures.
What does Class III mean?
FDA’s lowest-risk class: use of the product is not likely to cause adverse health consequences.
Where was it sold or shipped?
One customer in NC
What should I do if I have this product?
Compare the product name, size and lot or date codes with the details on this page. FDA recall notices often tell you to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information. If you are unsure, do not eat it.
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Sources
Data provided by the U.S. Food and Drug Administration (FDA) through openFDA, shown as published and not validated by this site. This site is independent and is not affiliated with or endorsed by FDA. It covers FDA-regulated foods; meat, poultry and egg products are regulated by USDA. Do not rely on this site for medical decisions: for health concerns contact a healthcare professional, and always follow the official notice and the company’s instructions. Terms and disclaimer.