# FDA recall D-0854-2016

> **Hospira Inc.** · Class III · drug recall initiated 2016-03-23.

## Product

Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.

## Reason for recall

Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

## Distribution

Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago

## Key facts

- **Recall number:** D-0854-2016
- **Recalling firm:** Hospira Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2016-03-23
- **Report date:** 2016-05-25

- **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-0854-2016

## Citation

> AI Analytics. FDA recall D-0854-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0854-2016. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
