Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center recalls PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/…

Recall date

October 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0147-2020

FDA classification

Class II

Brand / firm

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

Sold / distributed

Nationwide.

Why it was recalled

GMP Deviations: potential glass contamination

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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