PERFORMIX(TM) CREA-BEAD, MULTI-PHASE CREATINE, UNFLAVOURED, (a) 30 SERVINGS, UPC 8 11274…

Armada Nutrition recalled this product and the FDA reported the enforcement action on 3 May 2017 as Class II. The recall was initiated by the firm. A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium.

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

PERFORMIX(TM) CREA-BEAD, MULTI-PHASE CREATINE, UNFLAVOURED, (a) 30 SERVINGS, UPC 8 11274 02239 8; (b) 45 SERVINGS, Distributed by Performix LLC, 221 S. Cherokee St., Denver, CO 80223, UPC 8 11274 02203 8

UPC

811274022398

Reason for recall

A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium.

Recalling firm

Armada Nutrition

Firm location

Spring Hill, Tennessee, United States

Classification

Class II

Status

Terminated

Recall number

F-2148-2017

Quantity

39,273 units

Distribution

CO, NJ, England, South Africa,

Initiated

23 March 2017

Reported by FDA

3 May 2017

Terminated

14 February 2018

Firm notified by

Telephone

Product codes

(a) lot IM458501, Exp 10/2018 (b) lot IM447128, Exp 07/2018, lot IM445515

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 7 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 7 separate recalls, which almost every published figure does, overstates it by a factor of 7. 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 7 of them.
• The recall ran for 11 months, from 23 March 2017 to termination on 14 February 2018. 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 distribution pattern names 2 states, and the FDA published the enforcement report 6 weeks 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.

Named in the distribution pattern: Colorado, New Jersey. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

Other records from Armada Nutrition

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 6 other records name this firm.

All 7 records for Armada Nutrition

All 2017 recalls · All FDA food recall data