FDAClass IIJanuary 11, 2017

TriMix recall: Sterility Concern

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

Why was TriMix recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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).

Product
TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Recalling firm
Tri-Coast Pharmacy
Quantity
17 vials
Distribution
Nationwide
Recall date
January 11, 2017
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls