Food recall

Novis PR, LLC dba Kramer Novis recall: GPre Protein, Liquid predigested Protein, Dietary Supplement, Nt Wt

Novis PR, LLC dba Kramer Novis, of San Juan, PR, recalled GPre Protein, Liquid predigested Protein, Dietary Supplement, Nt Wt and 2 other products. The FDA's reason: “Bloated Protein Bottle.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on March 27, 2023, and the FDA first listed it in its Enforcement Report of May 10, 2023. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed August 15, 2023

The recall

Company
Novis PR, LLC dba Kramer Novis (San Juan, PR)
Reason, in FDA's words
“Bloated Protein Bottle”
Where it was sold
Domestic distribution only.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
92070

The 3 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-0810-2023 Class II

    GPre Protein, Liquid predigested Protein, Dietary Supplement, Nt Wt. 16 oz, plastic bottle packed 12 units of 16 oz in 1 case.

    Codes: lot 230118 UPC Code: 52083633164

    Quantity: 6,034 units

  • F-0811-2023 Class II

    PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, packed 200 units of 30mL in 1 case

    Codes: lot 230118 UPC Code:52083533105

    Quantity: 4106 units

  • F-0812-2023 Class II

    PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 16 oz Bottle, packed in 12 units of 16 oz. each per case.

    Codes: lot 230131 UPC Code:52083533167

    Quantity: 513 units

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of May 10, 2023.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.