FDAClass IIJanuary 11, 2017

Alprostadil 20 mcg/mL Injectable recall: Sterility Concern

Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL

Why was Alprostadil 20 mcg/mL Injectable recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 03312016@6 b) Known lot code: 04222016@8, 15202016@85, 06302016@4, 08012016@32

Product
Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
Recalling firm
Wells Pharmacy Network LLC
Quantity
a) 24 vials, b) 91 vials
Distribution
Nationwide
Recall date
January 11, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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