Drug 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
D-0023-2025
Product summary
- Event
- Event 95427
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1008 bags
- Official record key
drug-enforcement:D-0023-2025
Official wording
Reason: cGMP violations
Code information: Lot # C274-000037436, exp. date 30-Oct-24 C274-000038893, exp. date 7-Jan-25
Distribution pattern: Product was distributed to 125 direct accounts nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP violations