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Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy

FDA Recall #D-0299-2017 — Class II — November 17, 2016

Recall #D-0299-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 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

2,818 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016D (11/19/2016), 06162016A (12/13/2016), 06132016A (12/10/2016), 07282016I (01/24/2017), 08172016D (02/13/2017), 08042016C (01/31/2017), 09222016F (03/21/2017), 09062016A (02/28/2017), 10272016B (02/28/2017), 10252016D (02/28/2017), 08252016B (02/21/2017), 11022016C (05/01/2017).

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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