Recall Enforment Report D-0896-2021

Multi event Drug Recall Enforcement Report Class II voluntary initiated by IntegraDose Compounding Services LLC, originally initiated on 09-17-2021 for the product ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1 The product was recalled due to lack of sterility assurance.. The product was distributed in Nh, Ma, Mn and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0896-202109-17-202110-06-2021Class II2,614 syringesceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1Lack of sterility assurance.Ongoing
D-0897-202109-17-202110-06-2021Class II589 bagsceFAZolin 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: 71139-7153-1Lack of sterility assurance.Ongoing