D-1498-2014 Class II Terminated
FDA drug recall D-1498-2014 was initiated by Fagron, Inc on July 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 October 21, 2014). Affected quantity: 99 jars.
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
- 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