FDA Drug recall D-809-2013
Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manuf…
- FDA Drug
- Class I
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class I recall of Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manuf… by Mobius Therapeutics, citing non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-809-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-01-03 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mobius Therapeutics |
| Distribution | US |
Product
Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA.
Reason
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Identifiers
| ndc | 49771-002-01 |
|---|---|
| ndc | 49771-002-03 |
| code_info | Lot #: M086920 and M098260, Exp. 08/2013 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-809-2013%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.