January 11, 2017
Tri-Coast Pharmacy is recalling 161 vials of Infuvite IV (intravenous) 30 ML, according to the latest Drug Enforcement Report from the US Food and Drug Administration (January 11, 2017).
Infuvite is a multivitamin injection made up of Ascorbic Acid 200 mg+ Vitamin A Acetate 3300 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. It is indicated as a daily multivitamin maintenance supplement for adults and children aged 11 years and older. IV administration of the drug is often used in situations such as surgery, extensive burns, fractures and other trauma, severe infectious disease, and comatose states, which may provoke stressful scenarios with alterations in the body’s metabolic demands and consequent tissue depletion of nutrients.
According to the FDA’s report, the recall began on November 17, 2016 due to a lack of assurance of sterility. It will include all sterile products compounded between May 17, 2016 and November 17, 2016. Known lot numbers include: 07062016D, 08312016A, 08232016C, 08222016C, 08102016E, 08102016D, 08012016E, 09262016C, 09132016C.
The recall has been designated a class II, meaning that use or exposure to Infuvite IV may cause temporary or reversible adverse health consequences, but is unlikely to cause serious injury or death.
The recall is ongoing and across the United States—Sean McGuire
Enforcement Report. US Food and Drug Administration Website. http://www.accessdata.fda.gov/scripts/ires/index.cfm. Published January 11, 2017. Accessed January 11, 2017.