Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

FDA Recall #D-0303-2017 — Class II — November 17, 2016

Recall #D-0303-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 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

152 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07132016D (01/09/2017), 11072016B (05/06/2017).

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated