Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phos...

FDA Recall #D-0270-2017 — Class II — November 17, 2016

Recall #D-0270-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 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

987 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 09022016A (12/31/2016), 07282016C (12/31/2016)

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated