FDAClass IIJanuary 22, 2020

Alprostadil 40 mcg/mL recall: Sterility Concern

Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800

Why was Alprostadil 40 mcg/mL recalled?

Lack of sterility assurance.

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?

Lots: 09262019@13 Exp. 03/24/2020; 10072019@03/04/2020; 12062019@2 Exp. 06/03/2020; 12172019@12 Exp. 01/31/2020; 08142019@20 Exp. 02/10/2020

Product
Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800
Recalling firm
Assurance Infusion
Quantity
60 vials
Distribution
Nationwide within the United States
Recall date
January 22, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls