# FDA recall D-1431-2019

> **American Health Packaging** · Class II · drug recall initiated 2019-05-13.

## Product

Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by:  American Health Packaging, Columbus, Ohio 43217   NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25

## Reason for recall

GMP Deviations; possible cross contamination of product due to cleaning procedure failure.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1431-2019
- **Recalling firm:** American Health Packaging
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-13
- **Report date:** 2019-07-03
- **Termination date:** 2020-09-30

- **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-1431-2019

## Citation

> AI Analytics. FDA recall D-1431-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1431-2019. Source: US FDA. Licensed CC0.

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