# FDA recall D-1020-2018

> **RemedyRepack Inc.** · Class II · drug recall initiated 2018-07-17.

## Product

Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701

## Reason for recall

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

## Distribution

Product was distributed to 3 medical facilities in Florida.

## Key facts

- **Recall number:** D-1020-2018
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-17
- **Report date:** 2018-08-08
- **Termination date:** 2018-10-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indiana, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1020-2018

## Citation

> AI Analytics. FDA recall D-1020-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1020-2018. Source: US FDA. Licensed CC0.

---

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