# FDA recall D-0211-2018

> **Akorn Inc** · Class III · drug recall initiated 2017-12-15.

## Product

Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only.  Manufactured by: Hi-Tech Pharmacal Co., Inc.  Amityville, NY 11701.  NDC:  50383-311-47

## Reason for recall

CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0211-2018
- **Recalling firm:** Akorn Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-12-15
- **Report date:** 2018-01-17
- **Termination date:** 2019-04-10

- **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-0211-2018

## Citation

> AI Analytics. FDA recall D-0211-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0211-2018. Source: US FDA. Licensed CC0.

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