Gifted Nutrition 100% Bovine Colostrum, in plastic bottles, Ingredients: Skim Colostrum…

Nutrition Resource Services, Inc. recalled this product and the FDA reported the enforcement action on 28 October 2015 as Class II. The recall was initiated by the firm. Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk

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

Gifted Nutrition 100% Bovine Colostrum, in plastic bottles, Ingredients: Skim Colostrum, 30 servings, Gifted Nutrition Enterprises, Inc. , Miami, FL;

Reason for recall

Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk

Recalling firm

Nutrition Resource Services, Inc.

Firm location

Bethlehem, Pennsylvania, United States

Classification

Class II

Status

Terminated

Recall number

F-0061-2016

Quantity

3434 units Total

Distribution

Nationwide

Initiated

30 July 2015

Reported by FDA

28 October 2015

Terminated

5 December 2016

Firm notified by

Press Release

Product codes

Batch number: 226110162014 Lot number: 130817A.

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 38 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 38 separate recalls, which almost every published figure does, overstates it by a factor of 38. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 38 of them.
• The recall ran for 16 months, from 30 July 2015 to termination on 5 December 2016. 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 3 months after the firm began the recall.
• The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

Other records from Nutrition Resource Services, Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 37 other records name this firm.

All 38 records for Nutrition Resource Services, Inc.

All 2015 recalls · All FDA food recall data