# FDA recall D-1077-2020

> **Medical Center Pharmacy, Inc.** · Class II · drug recall initiated 2020-03-13.

## 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.

## Reason for recall

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

## Distribution

Specific prescriptions to patients in TN

## Key facts

- **Recall number:** D-1077-2020
- **Recalling firm:** Medical Center Pharmacy, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-13
- **Report date:** 2020-04-08
- **Termination date:** 2022-10-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cleveland, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1077-2020

## Citation

> AI Analytics. FDA recall D-1077-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1077-2020. Source: US FDA. Licensed CC0.

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