Drug product
Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL). 30 ML. Compounded by Tri-Coast Pharmacy.
D-0264-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 161 vials
- Official record key
drug-enforcement:D-0264-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date, if known): 07062016D (10/30/2016), 08312016A, 08232016C, 08222016C, 08102016E, 08102016D, 08012016E, 09262016C, 09132016C
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility