# FDA recall D-1041-2019

> **Camber Pharmaceuticals Inc** · Class II · drug recall initiated 2019-02-28.

## Product

Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India

## Reason for recall

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1041-2019
- **Recalling firm:** Camber Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-02-28
- **Report date:** 2019-03-27

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1041-2019

## Citation

> AI Analytics. FDA recall D-1041-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1041-2019. Source: US FDA. Licensed CC0.

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