# FDA recall D-0093-2019

> **RemedyRepack Inc.** · Class II · drug recall initiated 2018-08-24.

## Product

Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays  Original NDC 13668-0325-30  Repackaged NDC 70518-1220-00

## Reason for recall

CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.

## Distribution

Product was distributed to a medical facility in South Carolina

## Key facts

- **Recall number:** D-0093-2019
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-24
- **Report date:** 2018-10-31
- **Termination date:** 2018-10-29

- **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-0093-2019

## Citation

> AI Analytics. FDA recall D-0093-2019. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/D-0093-2019. Source: US FDA. Licensed CC0.

---

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