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Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

FDA Recall #D-0302-2017 — Class II — November 17, 2016

Recall #D-0302-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

Testosterone Cypionate in Sesame Oil, 250 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

1,244 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06272016A (12/24/2016), 08242016A (02/20/2017), 09212016B (03/20/2017), 07252016A (01/21/2017), 08112016B (02/07/2017), 10252016L (02/28/2017).

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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