Drug 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.
D-1496-2014
Product summary
- Firm
- Fagron, Inc
- Event
- Event 68896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 430 jars
- Official record key
drug-enforcement:D-1496-2014
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Code information: Lot # 13J30-U17-015413; Exp 10/15 Lot # 13J30-U16-015425; Exp 10/15 Lot # 13I06-U05-014199; Exp 10/15
Distribution pattern: Nationwide and Australia
Derived failure modes
-
Microbial contamination
Microbial Contamination