FDA-Drug2020-04-08Class II

*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.

Medical Center Pharmacy, Inc.
Hazard

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

Sold states
Specific prescriptions to patients in TN
Affected count
2 bottles
Manufactured in
2401 N Ocoee St, N/A, Cleveland, TN, United States
Products
*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.

Official notice

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

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