Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg...
FDA Recall #D-0308-2017 — Class II — November 17, 2016
Product Description
Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/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
78 vials
Distribution
Nationwide
Code Information
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07262016F (01/22/2017), 08092016A (02/05/2017), 09152016E (02/28/2017).
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated