# FDA recall D-0563-2016

> **Avantor Performance Materials Inc** · Class III · drug recall initiated 2015-10-30.

## Product

Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specifications results for impurities.

## Distribution

Distributed in the US including: CA, IL & NC; Canada

## Key facts

- **Recall number:** D-0563-2016
- **Recalling firm:** Avantor Performance Materials Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-10-30
- **Report date:** 2016-01-13
- **Termination date:** 2016-12-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0563-2016

## Citation

> AI Analytics. FDA recall D-0563-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0563-2016. Source: US FDA. Licensed CC0.

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