*Mitomycin 0.04% Ophth DR eye drops recall: Sterility Concern
*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.
Why was *Mitomycin 0.04% Ophth DR eye drops recalled?
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 03022020@5 BUD: 03/16/2020
- 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.
- Recalling firm
- Medical Center Pharmacy, Inc.
- Quantity
- 2 bottles
- Distribution
- Specific prescriptions to patients in TN
- Recall date
- April 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)