# FDA recall D-0422-2018

> **PharMEDium Services, LLC** · Class II · drug recall initiated 2018-02-05.

## Product

15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC

## Reason for recall

Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.

## Distribution

Product was distributed to SC, FL, NY, NY,WA

## Key facts

- **Recall number:** D-0422-2018
- **Recalling firm:** PharMEDium Services, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-05
- **Report date:** 2018-02-21
- **Termination date:** 2018-04-24

- **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-0422-2018

## Citation

> AI Analytics. FDA recall D-0422-2018. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/D-0422-2018. Source: US FDA. Licensed CC0.

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