# FDA recall D-1089-2020

> **PharMEDium Services, LLC** · Class II · drug recall initiated 2020-03-16.

## Product

fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL  Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44

## Reason for recall

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

## Distribution

Distributed Nationwide in the US

## Key facts

- **Recall number:** D-1089-2020
- **Recalling firm:** PharMEDium Services, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-16
- **Report date:** 2020-04-15
- **Termination date:** 2025-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dayton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1089-2020

## Citation

> AI Analytics. FDA recall D-1089-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1089-2020. Source: US FDA. Licensed CC0.

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