Home / Recalls / Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center / D-0151-2020

D-0151-2020 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
1047 bags

Product Description

del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10

Reason for Recall

Lack of Assurance of Sterility; bags have potential to leak

Distribution Pattern

Nationwide.

Code Information

Lots: NC9048A Exp. 10/14/2019; NC9048B Exp. 10/14/2019; NC9049A Exp. 10/16/2019; NC9049B Exp. 10/16/2019; NC9051A Exp. 10/21/2019; NC9051B Exp. 10/21/2019; NC9052A Exp. 10/22/2019; NC9052B Exp. 10/22/2019; NC9053A Exp. 10/23/2019; NC9053B Exp. 10/23/2019; NC9054A Exp. 10/28/2019; NC9054B Exp. 10/28/2019; NC9055A Exp. 10/30/2019; NC9056B Exp. 11/04/2019

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-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)