# FDA recall D-0076-2018

> **Amneal Pharmaceuticals LLC** · Class II · drug recall initiated 2017-08-31.

## Product

Fosphenytoin Sodium Injection, USP,  500 mg  PE/10 mL (50 mg PE/mL.  10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7

## Reason for recall

Presence of Particulate Matter

## Distribution

MS, NC, OH, TX, UT

## Key facts

- **Recall number:** D-0076-2018
- **Recalling firm:** Amneal Pharmaceuticals LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-31
- **Report date:** 2017-11-22
- **Termination date:** 2019-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Glasgow, KY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0076-2018

## Citation

> AI Analytics. FDA recall D-0076-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0076-2018. Source: US FDA. Licensed CC0.

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