Mitosol — Class I drug recall D-809-2013
Terminated recall by Mobius Therapeutics LLC, reported 2013-07-31, distributed nationwide. Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
| Recall number | D-809-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mobius Therapeutics LLC, Saint Louis, MO, United States |
| Recall initiated | 2013-01-03 |
| Classified | 2013-07-19 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2013-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 83 boxes |
| Reason classes | microbial contamination, sterility |
| Pathogens | yeast |
| NDC | 49771-0002, 49771-0002-01, 49771-0002-03 |
| Lot numbers | M086920, M098260 |
| Expiration dates | 2013-08 |
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 for recall
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
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-809-2013. 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.