FDA Drug recall D-0338-2019
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 2018-12-26
On 2018-12-26 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 Gordon Laboratories, citing superpotent Drug: contains higher levels of Iron than labeled.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0338-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-10 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Gordon Laboratories |
| 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
Superpotent Drug: contains higher levels of Iron than labeled.
Identifiers
| code_info | Batch #: 579602, 579604, 579606, Exp 12/18; 579609, Exp 04/19. |
|---|
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-0338-2019%22
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