FDAClass IIMay 16, 2018

Alprostadil 20 mcg/mL recall: Sterility Concern

Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc

Why was Alprostadil 20 mcg/mL recalled?

Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

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?

Lot #: 02122018@77, Exp 05/13/2018

Product
Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Recalling firm
Vitalab Pharmacy, Inc
Quantity
2 vials
Distribution
The recalled product was distributed to patients throughout the United States.
Recall date
May 16, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls