FDA Drug recall D-1528-2019
MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Lab…
- FDA Drug
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Lab… by Dercher Enterprises, citing microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron conte….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1528-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-19 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dercher Enterprises |
| Distribution | US |
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
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.
Identifiers
| code_info | Batch #: 579634, 579635, Exp 5/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1528-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.