# FDA recall D-1047-2019

> **American Health Packaging** · Class II · drug recall initiated 2019-03-06.

## Product

Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10)  per Unit Dose Blisters, Rx Only, Packaged and Distributed by:  American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)

## Reason for recall

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-1047-2019
- **Recalling firm:** American Health Packaging
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-06
- **Report date:** 2019-03-27
- **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-1047-2019

## Citation

> AI Analytics. FDA recall D-1047-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1047-2019. Source: US FDA. Licensed CC0.

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