Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + So...

FDA Recall #D-0277-2017 — Class II — November 17, 2016

Recall #D-0277-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml + Strontium Chloride 3 mg/ml + Lithium Citrate 5 mg/ml + Chromium Picolinate 100 mcg/ml + Boron Citrate 1798 mg/ml + Sodium Selenite 200 mcg.ml + Cupric Sulfate 1 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

36 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05182016B (11/14/2016), 08102016B (12/31/2016)

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated