FDAFDA · Food and drugs·Recall number 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 67457-0518-05.
Published April 8, 2020 · Recall initiated: March 13, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medical Center Pharmacy, Inc.
- Distributor
- Specific prescriptions to patients in TN
- Lot
- Lot: 03022020@5 BUD: 03/16/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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