# FDA recall D-1104-2020

> **Avet Pharmaceuticals, Inc.** · Class II · drug recall initiated 2020-03-26.

## Product

Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India  Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816

## 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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1104-2020
- **Recalling firm:** Avet Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-26
- **Report date:** 2020-04-15
- **Termination date:** 2021-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Brunswick, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1104-2020

## Citation

> AI Analytics. FDA recall D-1104-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1104-2020. Source: US FDA. Licensed CC0.

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