FDA recall D-1496-2014

Product

Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6.

Reason for recall

Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

Distribution

Nationwide and Australia

Key facts

Status

Terminated

Initiation date

2014-07-24

Report date

2014-08-06

Termination date

2014-10-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1496-2014