PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, packed 200 units of 30mL in 1 case
Summary
The FDA issued a Class II for PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, by Novis PR, LLC dba Kramer Novis. Reason: Bloated Protein Bottle.
Details
Source
Food Recall
External ID
F-0811-2023
Action Date
2023-05-10
Status
Terminated
Category
food
Product Description
PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, packed 200 units of 30mL in 1 case
Lot/Code Info: lot 230118 UPC Code:52083533105
Quantity Affected: 4106 units
Reason for Recall
Bloated Protein Bottle
Distribution
Domestic distribution only.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-27
Company
San Juan, PR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 65 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-0811-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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