FDA recall F-2148-2017

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

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.

Distribution

CO, NJ, England, South Africa,

Key facts

Status

Terminated

Initiation date

2017-03-23

Report date

2017-05-03

Termination date

2018-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Spring Hill, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-2148-2017