# FDA recall D-0339-2024

> **Ascend Laboratories, LLC** · Class II · drug recall initiated 2024-01-16.

## Product

Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57

## Reason for recall

Failed Impurities/Degradation Specification: Out of specification for organic impurities

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0339-2024
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-01-16
- **Report date:** 2024-02-28

- **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-0339-2024

## Citation

> AI Analytics. FDA recall D-0339-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0339-2024. Source: US FDA. Licensed CC0.

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