# FDA recall D-0147-2020

> **Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center** · Class II · drug recall initiated 2019-10-09.

## Product

PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625  in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25

## Reason for recall

GMP Deviations: potential glass contamination

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0147-2020
- **Recalling firm:** Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-09
- **Report date:** 2019-10-30
- **Termination date:** 2020-12-01

- **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-0147-2020

## Citation

> AI Analytics. FDA recall D-0147-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0147-2020. Source: US FDA. Licensed CC0.

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