Ultra Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50 mg/Methylcobalamin 1mg/Car...

FDA Recall #D-0324-2017 — Class II — November 17, 2016

Recall #D-0324-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

Ultra Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50 mg/Methylcobalamin 1mg/Carnitine (L) 170mg/Pyridoxine HCL 2mg/Lidocaine HCL 10mg/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

874 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06232016C (12/20/2016), 07272016B (12/31/2016), 08232016B (01/31/2017), 10262016D (02/28/2017), 09202016C (03/19/2016).

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated