D-1498-2014 Class II Terminated
FDA drug recall D-1498-2014 was initiated by Fagron, Inc on Jul 24, 2014 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. The recall status is terminated (terminated Oct 21, 2014). Affected quantity: 99 jars.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 6, 2014
- Initiation Date
- Jul 24, 2014
- Termination Date
- Oct 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99 jars
Product Description
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 Pattern
Nationwide and Australia
Code Information
Lot # 14C03-U09-017846; Exp. 03/17 Lot # 14B28-U06-017824; Exp. 03/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1498-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026