# FDA recall D-0251-2018

> **Premier Pharmacy Labs Inc** · Class II · drug recall initiated 2018-01-11.

## Product

Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.

## Reason for recall

Labeling: Label Error on Declared Strength

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0251-2018
- **Recalling firm:** Premier Pharmacy Labs Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-11
- **Report date:** 2018-02-07
- **Termination date:** 2020-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Weeki Wachee, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0251-2018

## Citation

> AI Analytics. FDA recall D-0251-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0251-2018. Source: US FDA. Licensed CC0.

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