# FDA recall D-1263-2019

> **Legacy Pharmaceutical Packaging LLC** · Class II · drug recall initiated 2019-04-24.

## Product

Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati,  OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920,  Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54

## Reason for recall

CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)

## Distribution

TN, AZ

## Key facts

- **Recall number:** D-1263-2019
- **Recalling firm:** Legacy Pharmaceutical Packaging LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-04-24
- **Report date:** 2019-05-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Earth City, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1263-2019

## Citation

> AI Analytics. FDA recall D-1263-2019. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-1263-2019. Source: US FDA. Licensed CC0.

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