Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center recalls PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (5…

Recall date

October 9, 2019

Source

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

Recall number

D-0148-2020

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 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25