Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
FDA Recall #D-0260-2017 — Class II — November 17, 2016
Product Description
Glutathione 200 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
367 vials
Distribution
Nationwide
Code Information
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06082016A (09/06/2016), 07052016C (10/03/2016), 08082016A (11/06/2016), 09132016D (12/12/2016), 10262016A (01/24/2016).
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated