Thiamine HCl 0.9% Sodium Chloride Injection USP recall: CGMP Deviations
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
Why was Thiamine HCl 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 # C274-000037436, exp. date 30-Oct-24 C274-000038893, exp. date 7-Jan-25
- Product
- 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
- Recalling firm
- Fresenius Kabi Compounding, LLC
- Quantity
- 1008 bags
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Recall date
- October 30, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)