# FDA recall D-1063-2018

> **Guardian Pharmacy Services** · Class II · drug recall initiated 2018-05-17.

## Product

Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

## Reason for recall

Lack of sterility assurance.

## Distribution

Texas

## Key facts

- **Recall number:** D-1063-2018
- **Recalling firm:** Guardian Pharmacy Services
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-05-17
- **Report date:** 2018-08-15
- **Termination date:** 2020-11-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dallas, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1063-2018

## Citation

> AI Analytics. FDA recall D-1063-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1063-2018. Source: US FDA. Licensed CC0.

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