Drug product
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,
D-1498-2014
Product summary
- Firm
- Fagron, Inc
- Event
- Event 68896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99 jars
- Official record key
drug-enforcement:D-1498-2014
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Code information: Lot # 14C03-U09-017846; Exp. 03/17 Lot # 14B28-U06-017824; Exp. 03/17
Distribution pattern: Nationwide and Australia
Derived failure modes
-
Microbial contamination
Microbial Contamination