CLASS II Drug recall · Reported 8 Apr 2020 · FDA Enforcement Report
*Mitomycin 0.04% Ophth DR eye drops recalled by Medical Center Pharmacy
Medical Center Pharmacy is recalling *Mitomycin 0.04% Ophth DR eye drops, distributed in Tennessee. The recall was initiated on 13 Mar 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1077-2020
- FDA event ID
- 85217
- Recalling firm
- Medical Center Pharmacy, Cleveland, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2020
- FDA classified
- 1 Apr 2020
- Reported
- 8 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 13 Mar 2020 | Recall initiated by company | |
| 1 Apr 2020 | Classified by FDA | +19 days |
| 8 Apr 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
*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.
Where it was distributed
Specific prescriptions to patients in TN
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Which lots are affected?
Lot: 03022020@5 BUD: 03/16/2020
Where was it sold?
Specific prescriptions to patients in TN
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 85217This product is part of a recall event; the main page for the event is C-*Vancomycin Opthal 14 mg drops recalled by Medical Center Pharmacy.
More recalls from Medical Center Pharmacy
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | C-*Gentamicin/Bacitracin Bladder Irrigation in N.S recalled | Medical Center Pharmacy | Sterility | TN |
| Drug | CLASS II | C-*Albumin Eye Drop recalled by Medical Center Pharmacy | Medical Center Pharmacy | Sterility | TN |
| Drug | CLASS II | *Morphine 2 mg/mL Cassette CADD Cassette recalled | Medical Center Pharmacy | Sterility | TN |
| Drug | CLASS II | C-*Vancomycin Opthal 14 mg drops recalled by Medical Center Pharmacy | Medical Center Pharmacy | Sterility | TN |