Vehicle Safety Product Safety Food Safety Pet Safety Drug Safety Device Safety Workplace Safety Bridge Safety Aviation Safety Dam Safety Nursing Homes Water Safety Railroad Safety Pipeline Safety Environmental

Testosterone Enanthate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

FDA Recall #D-0305-2017 — Class II — November 17, 2016

Recall #D-0305-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

Testosterone Enanthate in Sesame Oil, 200 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

1,567 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016C (11/19/2016), 08122016A (02/28/2017), 11012016J (04/30/2017), 07132016G (01/09/2017), 09012016B (02/28/2017), 09272016A (03/26/2017).

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

Back to All Drug Recalls