# FDA recall D-1102-2020

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2020-03-25.

## Product

LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00

## 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

Bulk product was distributed to one re-packager in California.

## Key facts

- **Recall number:** D-1102-2020
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2020-03-25
- **Report date:** 2020-04-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1102-2020

## Citation

> AI Analytics. FDA recall D-1102-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1102-2020. Source: US FDA. Licensed CC0.

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