*Mitomycin 0 recalled over sterility concerns
- Recall date
- March 13, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Medical Center Pharmacy, Inc. recalls *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN…
- Recall number
- D-1077-2020
- FDA classification
- Class II
- Brand / firm
- Medical Center Pharmacy, Inc.
- Sold / distributed
- Specific prescriptions to patients in TN
Why it was recalled
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
*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.
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