Home / Recalls / Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center / D-0150-2020

D-0150-2020 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
162 bags

Product Description

Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10

Reason for Recall

Lack of Assurance of Sterility; bags have potential to leak

Distribution Pattern

Nationwide.

Code Information

Lots: AA9023A Exp. 10/24/2019; AA9023B Exp. 10/24/2019

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-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)
  • D-0147-2020 Class II — PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chlorid (October 9, 2019)