# FDA recall D-0889-2018

> **Advanced Pharma Inc.** · Class II · drug recall initiated 2018-06-20.

## Product

fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX  77054, NDC 15082-210-72.

## Reason for recall

Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.

## Distribution

Distributed to one medical center in Fort Worth, TX.

## Key facts

- **Recall number:** D-0889-2018
- **Recalling firm:** Advanced Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-06-20
- **Report date:** 2018-07-04
- **Termination date:** 2019-04-03

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0889-2018

## Citation

> AI Analytics. FDA recall D-0889-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0889-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*