MONSEL'S — Class II drug recall D-1528-2019
Terminated recall by Dercher Enterprises, Inc., DBA Gordon Laboratories, reported 2019-07-31, distributed nationwide. Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamin
| Recall number | D-1528-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dercher Enterprises, Inc., DBA Gordon Laboratories, Upper Darby, PA, United States |
| Recall initiated | 2019-07-19 |
| Classified | 2019-07-25 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2023-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 277 boxes |
| Reason classes | microbial contamination, potency, sterility, specification failure |
| NDC | 10481-0112-08 |
| Lot numbers | 579634, 579635 |
| Expiration dates | 2020-05 |
Product
MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
Reason for recall
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
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-1528-2019. 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.