G-PREPROTEIN, Liquid Predigested Protein, Dietary Supplement, Cherry Flavor, Net Contents 16 fl oz (473 mL), Kramer Novi
Summary
The FDA issued a Class III for G-PREPROTEIN, Liquid Predigested Protein, Dietary Supplement, Cherry Flavor, Net by Novis PR, LLC dba Kramer Novis. Reason: Physical appearance of bottle of G-Pre Protein was atypical. Once opened, unusual odor was noticed and atypical bubbles were present..
Details
Source
Food Recall
External ID
F-0037-2023
Action Date
2022-10-19
Status
Terminated
Category
food
Product Description
G-PREPROTEIN, Liquid Predigested Protein, Dietary Supplement, Cherry Flavor, Net Contents 16 fl oz (473 mL), Kramer Novis
Lot/Code Info: Lot 080522, Exp Date 08/25
Quantity Affected: 1,369 units
Reason for Recall
Physical appearance of bottle of G-Pre Protein was atypical. Once opened, unusual odor was noticed and atypical bubbles were present.
Distribution
Domestic distribution only (Puerto Rico).
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-25
Company
San Juan, PR
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 40 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Novis PR, LLC dba Kramer Novis has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Novis PR, LLC dba Kramer Novis) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Novis PR, LLC dba Kramer Novis have FDA actions?
Novis PR, LLC dba Kramer Novis has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0037-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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