# FDA recall D-1133-2018

> **AVKARE Inc.** · Class II · drug recall initiated 2018-08-14.

## Product

Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

## Reason for recall

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

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-1133-2018
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-14
- **Report date:** 2018-09-05
- **Termination date:** 2020-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1133-2018

## Citation

> AI Analytics. FDA recall D-1133-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1133-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*