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

FDA recall notice · announced August 6, 2014 · Fagron

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

Notes

Distribution: Nationwide and Australia
Lot/code information: Lot # 13J30-U17-015413; Exp 10/15 Lot # 13J30-U16-015425; Exp 10/15 Lot # 13I06-U05-014199; Exp 10/15
Quantity: 430 jars
Status: Terminated
Products in this recall event:
- 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 (D-1498-2014)
- Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 24 (D-1497-2014)
- 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 (D-1496-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.