EPINEPHrine 0.9% Sodium Chloride Injection USP recall: CGMP Deviations
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
Why was EPINEPHrine 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 # C274-000038958, exp. date 17-Oct-24 C274-000039206, exp. date 23-Oct-24
- Product
- EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
- Recalling firm
- Fresenius Kabi Compounding, LLC
- Quantity
- 753 bags
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Recall date
- October 30, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)