PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: August 6, 2014 Initiated: July 24, 2014 #D-1497-2014

Product Description

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.

Details

Recalling Firm
Fagron, Inc
Units Affected
97 jars
Distribution
Nationwide and Australia
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Fagron, Inc. Units affected: 97 jars.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 6, 2014. Severity: Moderate. Recall number: D-1497-2014.