# FDA recall D-0359-2022

> **Ascend Laboratories, LLC** · Class II · drug recall initiated 2021-12-21.

## Product

Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50

## Reason for recall

Failed impurities/degradation specifications

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-0359-2022
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-12-21
- **Report date:** 2022-01-12
- **Termination date:** 2023-04-13

- **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-0359-2022

## Citation

> AI Analytics. FDA recall D-0359-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0359-2022. Source: US FDA. Licensed CC0.

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