Recalls / Class II
Class IID-1498-2014
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,
- Affected lot / code info
- Lot # 14C03-U09-017846; Exp. 03/17 Lot # 14B28-U06-017824; Exp. 03/17
Why it was recalled
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Recalling firm
- Firm
- Fagron, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 Pilot Knob Rd, Saint Paul, Minnesota 55120-1118
Distribution
- Quantity
- 99 jars
- Distribution pattern
- Nationwide and Australia
Timeline
- Recall initiated
- 2014-07-24
- FDA classified
- 2014-07-30
- Posted by FDA
- 2014-08-06
- Terminated
- 2014-10-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1498-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.