# FDA recall D-0974-2016

> **Aidarex Pharmaceuticals LLC** · Class III · drug recall initiated 2016-06-01.

## Product

CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01

## Reason for recall

CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.

## Distribution

IN, GA

## Key facts

- **Recall number:** D-0974-2016
- **Recalling firm:** Aidarex Pharmaceuticals LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-06-01
- **Report date:** 2016-06-15
- **Termination date:** 2016-10-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Corona, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0974-2016

## Citation

> AI Analytics. FDA recall D-0974-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0974-2016. Source: US FDA. Licensed CC0.

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