# FDA recall D-1354-2022

> **Nephron Sc Inc** · Class II · drug recall initiated 2022-08-10.

## Product

Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01

## Reason for recall

cGMP Deviations: deviations leading to potential cross-contamination.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-1354-2022
- **Recalling firm:** Nephron Sc Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-08-10
- **Report date:** 2022-08-24
- **Termination date:** 2024-09-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Columbia, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1354-2022

## Citation

> AI Analytics. FDA recall D-1354-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1354-2022. Source: US FDA. Licensed CC0.

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