# FDA recall D-1145-2023

> **Ascend Laboratories, LLC** · Class III · drug recall initiated 2023-07-18.

## Product

Fosfomycin Tromethamine Granules for Oral Solution, 3 g 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 Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

## Distribution

The recall product was distributed nationwide.

## Key facts

- **Recall number:** D-1145-2023
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-07-18
- **Report date:** 2023-09-13
- **Termination date:** 2026-02-19

- **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-1145-2023

## Citation

> AI Analytics. FDA recall D-1145-2023. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/D-1145-2023. Source: US FDA. Licensed CC0.

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