# FDA recall D-1166-2017

> **PharMedium Services, Llc** · Class II · drug recall initiated 2017-04-06.

## Product

Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732,   NDC 61553-605-52

## Reason for recall

Labeling: Not Elsewhere Classified-  Diluent used to compound product expired prior to the expiration date assigned to the compounded product.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1166-2017
- **Recalling firm:** PharMedium Services, Llc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-04-06
- **Report date:** 2017-09-27
- **Termination date:** 2020-01-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1166-2017

## Citation

> AI Analytics. FDA recall D-1166-2017. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-1166-2017. Source: US FDA. Licensed CC0.

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