# FDA recall D-0583-2018

> **Spirit Pharmaceuticals, LLC** · Class II · drug recall initiated 2018-01-10.

## Product

Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1

## Reason for recall

CGMP deviations: Ibuprofen is being recalled in response to previous recall

## Distribution

NY

## Key facts

- **Recall number:** D-0583-2018
- **Recalling firm:** Spirit Pharmaceuticals, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-10
- **Report date:** 2018-03-14
- **Termination date:** 2021-01-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0583-2018

## Citation

> AI Analytics. FDA recall D-0583-2018. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-0583-2018. Source: US FDA. Licensed CC0.

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