Fagron — Class II drug recall D-1497-2014
Terminated recall by Fagron, Inc, reported 2014-08-06, distributed nationwide. Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
| Recall number | D-1497-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fagron, Inc, Saint Paul, MN, United States |
| Recall initiated | 2014-07-24 |
| Classified | 2014-07-30 |
| Reported by FDA | 2014-08-06 |
| Terminated | 2014-10-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 97 jars |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold |
| NDC | 51552-0919-08 |
| Lot numbers | 03/17, 14C24-U04-018189, 14C26-U02-018214 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1497-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.