Recalls / Class II
Class IID-1496-2014
Product
Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6.
- Affected lot / code info
- Lot # 13J30-U17-015413; Exp 10/15 Lot # 13J30-U16-015425; Exp 10/15 Lot # 13I06-U05-014199; Exp 10/15
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
- 430 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-1496-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.