# FDA recall D-0658-2016

> **Pharmedium Services, LLC** · Class I · drug recall initiated 2015-05-22.

## Product

Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44.

## Reason for recall

Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.

## Distribution

WI

## Key facts

- **Recall number:** D-0658-2016
- **Recalling firm:** Pharmedium Services, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-05-22
- **Report date:** 2016-02-17
- **Termination date:** 2016-02-18

- **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-0658-2016

## Citation

> AI Analytics. FDA recall D-0658-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0658-2016. Source: US FDA. Licensed CC0.

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