Fresenius Kabi Compounding, LLC: Drug Recall

Recall #D-0023-2025 · 09/25/2024

Class II: Risk

Recall Details

Recall Number
D-0023-2025
Classification
Class II
Product Type
Drug
Recalling Firm
Fresenius Kabi Compounding, LLC
Status
Terminated
Date Initiated
09/25/2024
Location
Canton, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1008 bags

Reason for Recall

cGMP violations

Product Description

Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

Distribution Pattern

Product was distributed to 125 direct accounts nationwide.

Other Recalls by Fresenius Kabi Compounding, LLC

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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.