# FDA recall D-379-2014

> **Fresenius Kabi USA, LLC** · Class III · drug recall initiated 2013-12-06.

## Product

FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11

## Reason for recall

Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point

## Distribution

Nationwide, Puerto Rico, Canada, New Zealand

## Key facts

- **Recall number:** D-379-2014
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-12-06
- **Report date:** 2013-12-25
- **Termination date:** 2015-05-21

- **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-379-2014

## Citation

> AI Analytics. FDA recall D-379-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-379-2014. Source: US FDA. Licensed CC0.

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