IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg...
FDA Recall #D-0265-2017 — Class II — November 17, 2016
Product Description
IV Cocktail #2 (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
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Tri-Coast Pharmacy — Juno Beach, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
132 vials
Distribution
Nationwide
Code Information
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date, if known): 05252016D (05/28/2016), 05202016A (05/23/2016), 05182016C (05/21/2016), 05092016C (05/12/2016), 05022016C (05/05/2016), 06132016D (06/16/2016), 06072016A (06/10/2016), 06062016A (06/09/2016), 07282106E (07/31/2016), 07252016G (07/28/2016), 09122016A (09/15/2016), 09192016B (09/22/2016)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated