# FDA recall D-1497-2014

> **Fagron, Inc** · Class II · drug recall initiated 2014-07-24.

## Product

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. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.

## Reason for recall

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

## Distribution

Nationwide and Australia

## Key facts

- **Recall number:** D-1497-2014
- **Recalling firm:** Fagron, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-07-24
- **Report date:** 2014-08-06
- **Termination date:** 2014-10-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1497-2014

## Citation

> AI Analytics. FDA recall D-1497-2014. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1497-2014. Source: US FDA. Licensed CC0.

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