FDAHealthSeptember 25, 2024
Fresenius Kabi Compounding, LLC — 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
⚠️ cGMP violations
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 25, 2024
Product was distributed to 125 direct accounts nationwide.
What's affected?
- 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
- Lot code
- C274-000037436
Additional details
Lot # C274-000037436, exp. date 30-Oct-24 C274-000038893, exp. date 7-Jan-25
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1008 bags.
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