# FDA recall D-0264-2021

> **Ascend Laboratories LLC** · Class II · drug recall initiated 2021-01-22.

## Product

Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68

## Reason for recall

CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0264-2021
- **Recalling firm:** Ascend Laboratories LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-01-22
- **Report date:** 2021-02-24
- **Termination date:** 2022-12-02

- **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-0264-2021

## Citation

> AI Analytics. FDA recall D-0264-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0264-2021. Source: US FDA. Licensed CC0.

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