# FDA recall D-0637-2017

> **X-Gen Pharmaceuticals Inc.** · Class I · drug recall initiated 2017-02-08.

## Product

Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.

## Reason for recall

Presence of Particulate Matter

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0637-2017
- **Recalling firm:** X-Gen Pharmaceuticals Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-08
- **Report date:** 2017-04-12
- **Termination date:** 2020-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horseheads, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0637-2017

## Citation

> AI Analytics. FDA recall D-0637-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0637-2017. Source: US FDA. Licensed CC0.

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