FDA recall D-1498-2014

Product

Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Pre served and fragrance-free, Manufactured by: Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120, NDC 51552-1285-8,

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-1498-2014