# FDA recall D-1083-2019

> **H J Harkins Company Inc dba Pharma Pac** · Class II · drug recall initiated 2019-03-04.

## Product

Losartan Potassium 100 mg Tablets # 30  Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H"  on one side and "145" on the other side.

## Reason for recall

CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).

## Distribution

Product was distributed to a physician's office in California.

## Key facts

- **Recall number:** D-1083-2019
- **Recalling firm:** H J Harkins Company Inc dba Pharma Pac
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-04
- **Report date:** 2019-04-17
- **Termination date:** 2023-05-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1083-2019

## Citation

> AI Analytics. FDA recall D-1083-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1083-2019. Source: US FDA. Licensed CC0.

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