The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1496-2014·Announced 2014-08-06

Fagron Recalls Phytobase Cream Lots Due to Mold Contamination

Fagron is recalling six lots of Phytobase Cream, a prescription compounding vehicle, due to the presence of mold.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves microbial contamination (mold) in a non-sterile product. Per the rubric, high-risk pathogens or risk-of-harm products where injury has not yet been reported are classified as High (Score 3). No illnesses or injuries are reported in the source text.

Plain-English summary

Fagron, Inc. is recalling six lots of Phytobase Cream, 500 g, Article number 802156. This product is a prescription-only natural self-emulsifying oil-in-water vehicle used for prescription compounding of oil-soluble ingredients. It contains phytosomes (plant oil bodies) and is manufactured by Fagron, Inc. in St. Paul, Minnesota.

The recall is being conducted due to the presence of mold in the non-sterile product. The affected lots are identified by the following lot numbers and expiration dates: Lot # 13J30-U17-015413 (Exp 10/15), Lot # 13J30-U16-015425 (Exp 10/15), and Lot # 13I06-U05-014199 (Exp 10/15). The source text indicates a total of six lots are involved, though only three specific lot numbers are listed in the provided structured data.

The product was distributed nationwide and in Australia. A total of 430 jars are affected. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or Fagron, Inc. for further instructions.

The recalled product

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…
Manufacturer
Fagron, Inc
Category
Drug — Compounding Ingredient
Hazard
Affected units
430

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot # 13J30-U17-015413
  • Exp 10/15 Lot # 13J30-U16-015425
  • Exp 10/15 Lot # 13I06-U05-014199
  • Exp 10/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Fagron, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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