FDA recall D-1497-2014

Product

Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.

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-1497-2014