# FDA recall D-0871-2016

> **Pharmakon Pharmaceuticals** · Class I · drug recall initiated 2016-02-11.

## Product

Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride,  Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.

## Reason for recall

Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.

## Distribution

IN and IL

## Key facts

- **Recall number:** D-0871-2016
- **Recalling firm:** Pharmakon Pharmaceuticals
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-02-11
- **Report date:** 2016-06-01
- **Termination date:** 2017-05-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Noblesville, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0871-2016

## Citation

> AI Analytics. FDA recall D-0871-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0871-2016. Source: US FDA. Licensed CC0.

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