FDA Drug recall D-1077-2020
*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-05…
- FDA Drug
- Class II
- terminated
- Published 2020-04-08
On 2020-04-08 the FDA classified a Class II recall of *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-05… by Medical Center Pharmacy, citing lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1077-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-13 |
| Published | 2020-04-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Medical Center Pharmacy |
| Distribution | TN |
Product
*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
Reason
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Identifiers
| code_info | Lot: 03022020@5 BUD: 03/16/2020 |
|---|
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-1077-2020%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.