MIC Ultra Cocktail (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 700mc...

FDA Recall #D-0276-2017 — Class II — November 17, 2016

Recall #D-0276-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

MIC Ultra Cocktail (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 700mcg/Chromium Picolinate 20 mcg/Pyridoxine HCL 2mg/ml), (10 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

278 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06132016B (11/30/2016), 08042016B (12/31/2016), 08252016A (12/31/2016)

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated