Home / Recalls / Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center / D-0148-2020

D-0148-2020 Class II Terminated

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

FDA drug recall D-0148-2020 was initiated by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center on October 9, 2019 and is designated Class II. Reason for recall: GMP Deviations: potential glass contamination The recall status is terminated (terminated December 1, 2020). Affected quantity: 1370 bags.

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
1370 bags

Product Description

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 Pattern

Nationwide.

Code Information

Lots: FB9014A Exp. 12/09/2019; FB9017A Exp. 12/16/2019

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-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-0149-2020 Class II — PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Inj (October 9, 2019)
  • D-0151-2020 Class II — del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron (October 9, 2019)
  • D-0147-2020 Class II — PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chlorid (October 9, 2019)

FDA data resources