# FDA recall D-0502-2018

> **American Pharmaceutical Ingredients LLC** · Class II · drug recall initiated 2018-02-09.

## Product

Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b) 1000g (NDC 58597-8353-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

## Reason for recall

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

## Distribution

Nationwide within USA.

## Key facts

- **Recall number:** D-0502-2018
- **Recalling firm:** American Pharmaceutical Ingredients LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-09
- **Report date:** 2018-02-28
- **Termination date:** 2019-12-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waterford, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0502-2018

## Citation

> AI Analytics. FDA recall D-0502-2018. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/D-0502-2018. Source: US FDA. Licensed CC0.

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