# FDA recall D-1428-2015

> **Pharmedium Services, LLC** · Class II · drug recall initiated 2015-07-21.

## Product

Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48

## Reason for recall

Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.

## Distribution

VA, IL, PA, ID

## Key facts

- **Recall number:** D-1428-2015
- **Recalling firm:** Pharmedium Services, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-21
- **Report date:** 2015-09-16
- **Termination date:** 2015-09-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1428-2015

## Citation

> AI Analytics. FDA recall D-1428-2015. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1428-2015. Source: US FDA. Licensed CC0.

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