# FDA recall D-0011-2015

> **Unique Pharmaceutical, Ltd** · Class I · drug recall initiated 2014-07-18.

## Product

N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133

## Reason for recall

Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0011-2015
- **Recalling firm:** Unique Pharmaceutical, Ltd
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-07-18
- **Report date:** 2014-10-15
- **Termination date:** 2016-02-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Temple, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0011-2015

## Citation

> AI Analytics. FDA recall D-0011-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0011-2015. Source: US FDA. Licensed CC0.

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