# FDA recall D-1584-2019

> **American Health Packaging** · Class III · drug recall initiated 2019-02-19.

## Product

Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.

## Reason for recall

CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

## Distribution

Nationwide within the USA and Puerto Rico

## Key facts

- **Recall number:** D-1584-2019
- **Recalling firm:** American Health Packaging
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-19
- **Report date:** 2019-08-14
- **Termination date:** 2020-09-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1584-2019

## Citation

> AI Analytics. FDA recall D-1584-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1584-2019. Source: US FDA. Licensed CC0.

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