TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast...

FDA Recall #D-0314-2017 — Class II — November 17, 2016

Recall #D-0314-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL, (1 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

8 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06012016E (07/16/2016), 09272016B (11/06/2016), 10032016G (11/14/2016), 11012016D (12/09/2016).

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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