# FDA recall D-1302-2016

> **Pharmakon Pharmaceuticals, Inc.** · Class II · drug recall initiated 2016-04-20.

## Product

Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride,  50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA

## Key facts

- **Recall number:** D-1302-2016
- **Recalling firm:** Pharmakon Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-04-20
- **Report date:** 2016-07-20
- **Termination date:** 2018-01-11

- **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-1302-2016

## Citation

> AI Analytics. FDA recall D-1302-2016. Retrieved 2026-05-30 from https://api.ai-analytics.org/recall/D-1302-2016. Source: US FDA. Licensed CC0.

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