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

FDA Recall #D-0300-2017 — Class II — November 17, 2016

Recall #D-0300-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

Testosterone Cypionate 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

7,168 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05252016A (11/21/2016), 06272016B (12/24/2016), 07262016D (01/22/2017), 07182016H (01/14/2017), 07182016G (01/14/2017), 08252016C (02/21/2017), 08222016B (02/18/2017), 08102016A (02/06/2017), 09282016D (03/27/2017), 09222016E (03/21/2017), 09152016A (02/28/2017), 09062016B (02/28/2017), 10252016C (02/28/2017), 10042016E (04/02/2017).

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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