Home / Recalls / IntegraDose Compounding Services LLC / D-0432-2024

D-0432-2024 Class II Ongoing

Recalled by IntegraDose Compounding Services LLC — Minneapolis, MN

Recall Details

Product Type
Drugs
Report Date
April 10, 2024
Initiation Date
March 22, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
187 cassettes

Product Description

fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1

Reason for Recall

Lack of Assurance of Sterility: leaking bags

Distribution Pattern

Nationwide within the U.S

Code Information

Lot#: 20231020FEN-1, Exp: 04/17/2024

Other recalls by IntegraDose Compounding Services LLC

  • D-0015-2026 Class I — Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, I (September 16, 2025)
  • D-0325-2024 Class II — Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, (January 22, 2024)
  • D-0258-2024 Class II — Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 (January 12, 2024)
  • D-0896-2021 Class II — ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, Inte (September 17, 2021)
  • D-0897-2021 Class II — ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product (September 17, 2021)