G-PREPROTEIN, Liquid Predigested Protein, Dietary Supplement, Cherry Flavor, Net…

Novis PR, LLC dba Kramer Novis recalled this product and the FDA reported the enforcement action on 19 October 2022 as Class III. The recall was initiated by the firm. Physical appearance of bottle of G-Pre Protein was atypical. Once opened, unusual odor was noticed and atypical bubbles were present.

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

G-PREPROTEIN, Liquid Predigested Protein, Dietary Supplement, Cherry Flavor, Net Contents 16 fl oz (473 mL), Kramer Novis

Reason for recall

Physical appearance of bottle of G-Pre Protein was atypical. Once opened, unusual odor was noticed and atypical bubbles were present.

Recalling firm

Novis PR, LLC dba Kramer Novis

Firm location

San Juan, Puerto Rico, United States

Classification

Class III

Status

Terminated

Recall number

F-0037-2023

Quantity

1,369 units

Distribution

Domestic distribution only (Puerto Rico).

Initiated

25 August 2022

Reported by FDA

19 October 2022

Terminated

14 December 2022

Firm notified by

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

Product codes

Lot 080522, Exp Date 08/25

Reading this record

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

• Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 record is the only one the FDA opened for its recall event, so it covers a single product code.
• The recall ran for 4 months, from 25 August 2022 to termination on 14 December 2022. 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 8 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.

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

Other dietary supplements recalls

These are the closest records in the corpus: the same kind of food. 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 2022 recalls · All FDA food recall data