D-1497-2014 Class II Terminated

Recalled by Fagron, Inc — Saint Paul, MN

Recall Details

Product Type
Drugs
Report Date
August 6, 2014
Initiation Date
July 24, 2014
Termination Date
October 21, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
97 jars

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.

Distribution Pattern

Nationwide and Australia

Code Information

Lot # 14C24-U04-018189; Exp. 03/17 Lot # 14C26-U02-018214; Exp. 03/17