# FDA recall D-920-2013

> **Fresenius Kabi USA, LLC** · Class I · drug recall initiated 2013-05-25.

## Product

Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50

## Reason for recall

Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-920-2013
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-25
- **Report date:** 2013-09-04
- **Termination date:** 2016-03-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-920-2013

## Citation

> AI Analytics. FDA recall D-920-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-920-2013. Source: US FDA. Licensed CC0.

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