FDAClass IIOctober 30, 2024

Oxytocin 0.9% Sodium Chloride Injection USP recall: CGMP Deviations

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

Why was Oxytocin 0.9% Sodium Chloride Injection USP recalled?

cGMP violations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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
Recalling firm
Fresenius Kabi Compounding, LLC
Quantity
4436 bags
Distribution
Product was distributed to 125 direct accounts nationwide.
Recall date
October 30, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls