FDA recall D-1077-2020

Medical Center Pharmacy, Inc. · Class II · drug

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 for recall

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Distribution

Specific prescriptions to patients in TN

Key facts

Status
Terminated
Initiation date
2020-03-13
Report date
2020-04-08
Termination date
2022-10-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cleveland, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1077-2020