# FDA recall D-1460-2019

> **Macleods Pharma Usa Inc** · Class II · drug recall initiated 2019-06-20.

## Product

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP  Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536   Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA     NDC 33342-051-10

## Reason for recall

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1460-2019
- **Recalling firm:** Macleods Pharma Usa Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-06-20
- **Report date:** 2019-07-17
- **Termination date:** 2021-10-26

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1460-2019

## Citation

> AI Analytics. FDA recall D-1460-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1460-2019. Source: US FDA. Licensed CC0.

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