IntegraDose Compounding Services LLC: Drug Recall

Recall #D-0896-2021 · 09/17/2021

Class II: Risk

Recall Details

Recall Number: D-0896-2021
Classification: Class II
Product Type: Drug
Recalling Firm: IntegraDose Compounding Services LLC
Status: Terminated
Date Initiated: 09/17/2021
Location: Minneapolis, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,614 syringes

Reason for Recall

Lack of sterility assurance.

Product Description

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

Distribution Pattern

NH, MA, MN

Other Recalls by IntegraDose Compounding Services LLC

Class I: Dangerous 09/16/2025

Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Class II: Risk 03/22/2024

Lack of Assurance of Sterility: leaking bags
Class II: Risk 01/22/2024

Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Class II: Risk 01/12/2024

Subpotent Drug
Class II: Risk 09/17/2021

Lack of sterility assurance.

View all recalls by IntegraDose Compounding Services LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.