# FDA recall D-1347-2022

> **Nephron Sterile Compounding Center LLC** · Class II · drug recall initiated 2022-08-10.

## Product

PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34

## Reason for recall

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1347-2022
- **Recalling firm:** Nephron Sterile Compounding Center LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-08-10
- **Report date:** 2022-08-24
- **Termination date:** 2024-10-11

- **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-1347-2022

## Citation

> AI Analytics. FDA recall D-1347-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1347-2022. Source: US FDA. Licensed CC0.

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