# FDA recall D-1281-2019

> **Preferred Pharmaceuticals, Inc** · Class II · drug recall initiated 2019-04-30.

## Product

Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ

## Reason for recall

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

## Distribution

CA, GA, IN. No DOD/VA accounts. No foreign accounts.

## Key facts

- **Recall number:** D-1281-2019
- **Recalling firm:** Preferred Pharmaceuticals, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-30
- **Report date:** 2019-05-22
- **Termination date:** 2023-04-03

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1281-2019

## Citation

> AI Analytics. FDA recall D-1281-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1281-2019. Source: US FDA. Licensed CC0.

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