Ascorbic Acid 500 mg/mL (50 ML). Compounded by Tri-Coast Pharmacy.
FDA Recall #D-0248-2017 — Class II — November 17, 2016
Product Description
Ascorbic Acid 500 mg/mL (50 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
201 vials
Distribution
Nationwide
Code Information
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07192016WW (01/15/2017), 07152016G (01/11/2017), 08292016A (02/25/2017), 10262016B (02/28/2017).
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated