GPre Protein, Liquid predigested Protein, Dietary Supplement, Nt Wt. 16 oz, plastic…

Novis PR, LLC dba Kramer Novis recalled this product and the FDA reported the enforcement action on 10 May 2023 as Class II. The recall was initiated by the firm. Bloated Protein Bottle

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product

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

Reason for recall

Bloated Protein Bottle

Recalling firm

Novis PR, LLC dba Kramer Novis

Firm location

San Juan, Puerto Rico, United States

Classification

Class II

Status

Terminated

Recall number

F-0810-2023

Quantity

6,034 units

Distribution

Domestic distribution only.

Initiated

27 March 2023

Reported by FDA

10 May 2023

Terminated

15 August 2023

Firm notified by

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Product codes

lot 230118 UPC Code: 52083633164

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

• Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
• The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
• This is one of 3 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 3 separate recalls, which almost every published figure does, overstates it by a factor of 3. All 3 of them are listed on this page.
• The recall ran for 5 months, from 27 March 2023 to termination on 15 August 2023. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
• The FDA published the enforcement report 6 weeks after the firm began the recall.
• Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.

What this recall was for

Filed under dietary supplements. A product can sit in more than one.

Every product in this recall

The FDA opened 3 enforcement records for this one recall, one per product code. This page carries all of them; the 2 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

Other dietary supplements recalls for the same reason

These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

Other records from Novis PR, LLC dba Kramer Novis

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

All 4 records for Novis PR, LLC dba Kramer Novis

All 2023 recalls · All FDA food recall data