# FDA recall D-1081-2019

> **RemedyRepack Inc.** · Class II · drug recall initiated 2019-03-14.

## Product

Losartan 50mg Tablet, 30 count each blister card.

## Reason for recall

CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).

## Distribution

Product was distributed to one sole customer, Miami, FL.

## Key facts

- **Recall number:** D-1081-2019
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-14
- **Report date:** 2019-04-17
- **Termination date:** 2019-04-11

- **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-1081-2019

## Citation

> AI Analytics. FDA recall D-1081-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1081-2019. Source: US FDA. Licensed CC0.

---

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