The Recall Desk
SevereFDA (Drugs)·D-1077-2020·Announced 2020-04-08

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
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.

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Same hazard · sterility

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