Medical Center Pharmacy Recalls Mitomycin Eye Drops Due to Sterility Concerns
Medical Center Pharmacy is recalling two bottles of Mitomycin 0.04% Ophth DR eye drops because production processes could not assure sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterile products where sterility assurance is compromised.
Plain-English summary
Medical Center Pharmacy, Inc. is recalling two bottles of Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only. The product is identified by NDC 67457-0518-05, Lot 03022020@5, and a Beyond Use Date of 03/16/2020.
The recall was initiated due to a lack of assurance of sterility. The firm cited concerns with production processes that could not assure the sterility of products intended to be sterile.
The affected product was distributed via specific prescriptions to patients in Tennessee. Patients who have received this product should contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- 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.
- Manufacturer
- Medical Center Pharmacy, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 03022020@5 BUD: 03/16/2020
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Medical Center Pharmacy, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Medical Center Pharmacy, Inc.
See all →- SevereMedical Center Pharmacy Recalls C-Albumin Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2020-04-08
- SevereMorphine 2 mg/mL CADD Cassettes Recalled for Sterility Concerns
FDA (Drugs) · 2020-04-08
- SevereMedical Center Pharmacy Recalls Vancomycin Opthal Drops Due to Sterility Concerns
FDA (Drugs) · 2020-04-08
- SevereMedical Center Pharmacy Recalls Gentamicin Bladder Irrigation Bags
FDA (Drugs) · 2020-04-08
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighMitomycin Ophthalmic Solution Recalled Nationwide Over Sterility Assurance
FDA (Drugs) · 2023-02-01
- SevereMitomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- HighFDA Recalls Mitomycin Ophthalmic Solution for Sterility Assurance Failure
FDA (Drugs) · 2023-02-01
- SevereFDA Recalls Atropine Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2019-04-24
- HighAcetylcysteine eye drops recalled for sterility assurance defect
FDA (Drugs) · 2022-11-09
- SevereMeta Pharmacy Recalls Compounded Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2016-12-28