# FDA recall D-1053-2019

> **Rising Pharmaceuticals, Inc.** · Class II · drug recall initiated 2019-03-07.

## Product

Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by:  Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-123-90

## Reason for recall

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

## Distribution

Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.

## Key facts

- **Recall number:** D-1053-2019
- **Recalling firm:** Rising Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-03-07
- **Report date:** 2019-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saddle Brook, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1053-2019

## Citation

> AI Analytics. FDA recall D-1053-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1053-2019. Source: US FDA. Licensed CC0.

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