# FDA recall D-1027-2018

> **Bryant Ranch Prepack Inc.** · Class II · drug recall initiated 2018-07-27.

## Product

Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

## Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

## Distribution

Product was distributed in HI, IN, and FL.

## Key facts

- **Recall number:** D-1027-2018
- **Recalling firm:** Bryant Ranch Prepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-27
- **Report date:** 2018-08-08
- **Termination date:** 2021-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burbank, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1027-2018

## Citation

> AI Analytics. FDA recall D-1027-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1027-2018. Source: US FDA. Licensed CC0.

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