Home / Recalls / Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center / D-0147-2020

D-0147-2020 Class II Terminated

Recalled by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center — West Columbia, SC

Recall Details

Product Type
Drugs
Report Date
October 30, 2019
Initiation Date
October 9, 2019
Termination Date
December 1, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1855 bags

Product Description

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 Pattern

Nationwide.

Code Information

Lots: FB9001 A Exp. 10/31/2019, FB9001B Exp. 10/31/2019; FB9013A Exp. 12/08/2019; FB9015A Exp. 12/14/2019

Other recalls by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

  • D-0154-2020 Class III — PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Sin (October 21, 2019)
  • D-0151-2020 Class II — del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron (October 9, 2019)
  • D-0150-2020 Class II — Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine (October 9, 2019)
  • D-0148-2020 Class II — PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride I (October 9, 2019)
  • D-0149-2020 Class II — PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Inj (October 9, 2019)