D-0021-2025 Class II Terminated

Recalled by Fresenius Kabi Compounding, LLC — Canton, MA

Recall Details

Product Type
Drugs
Report Date
October 30, 2024
Initiation Date
September 25, 2024
Termination Date
August 15, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4436 bags

Product Description

Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

Reason for Recall

cGMP violations

Distribution Pattern

Product was distributed to 125 direct accounts nationwide.

Code Information

Lot # C274-000038801, exp. date 9-Oct-24 C274-000039045, exp. date 24-Oct-24 C274-000039240, exp. date 31-Oct-24