FDAFDA · Food and drugs·Recall number D-1498-2014
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,
Published August 6, 2014 · Recall initiated: July 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fagron, Inc
- Distributor
- Nationwide and Australia
- Lot
- Lot # 14C03-U09-017846; Exp. 03/17 Lot # 14B28-U06-017824; Exp. 03/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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