Home / Recalls / IntegraDose Compounding Services LLC / D-0897-2021

D-0897-2021 Class II Terminated

Recalled by IntegraDose Compounding Services LLC — Minneapolis, MN

Recall Details

Product Type
Drugs
Report Date
October 6, 2021
Initiation Date
September 17, 2021
Termination Date
October 2, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
589 bags

Product Description

ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

NH, MA, MN

Code Information

Lot, expiry: 20210722CEF-2, exp 09/20/2021; 20210728CEF-1, exp 09/26/2021

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-0432-2024 Class II — fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, Inte (March 22, 2024)
  • 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)