FDA recall D-0148-2020

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center · Class II · drug

Product

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

Reason for recall

GMP Deviations: potential glass contamination

Distribution

Nationwide.

Key facts

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0148-2020