# FDA recall D-0222-2018

> **AVKARE Inc.** · Class II · drug recall initiated 2018-01-03.

## Product

Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.

## Reason for recall

Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0222-2018
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-03
- **Report date:** 2018-01-24
- **Termination date:** 2020-05-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0222-2018

## Citation

> AI Analytics. FDA recall D-0222-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0222-2018. Source: US FDA. Licensed CC0.

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