Home / Recalls / SCA Pharmaceuticals, LLC / D-0400-2024

D-0400-2024 Class II Terminated

Recalled by SCA Pharmaceuticals, LLC — Windsor, CT

Recall Details

Product Type
Drugs
Report Date
April 3, 2024
Initiation Date
November 9, 2023
Termination Date
August 27, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
412 cassettes

Product Description

fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 1223049261, Exp 12/25/23; 1223049724, Exp 01/11/24

Other recalls by SCA Pharmaceuticals, LLC

  • D-0396-2024 Class II — fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE (November 9, 2023)
  • D-0416-2024 Class II — PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration (November 9, 2023)
  • D-0417-2024 Class II — PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentrati (November 9, 2023)
  • D-0395-2024 Class II — fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 (November 9, 2023)
  • D-0421-2024 Class II — PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentratio (November 9, 2023)
  • D-0414-2024 Class II — PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentrati (November 9, 2023)
  • D-0410-2024 Class II — HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration (November 9, 2023)
  • D-0408-2024 Class II — HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration (November 9, 2023)
  • D-0422-2024 Class II — Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/m (November 9, 2023)
  • D-0401-2024 Class II — fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL I (November 9, 2023)