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TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL, (1 ML). Compounded by Tri-Coast P...

FDA Recall #D-0318-2017 — Class II — November 17, 2016

Recall #D-0318-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/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

17 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07282016G (09/08/2016), 07082016E (08/22/2016), 07142016D (08/22/2016).

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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