FDAClass IIJuly 28, 2021

Compounded Lyophilized AOD-9604 recall: Sterility Concern

Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Why was Compounded Lyophilized AOD-9604 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?

Lot #: AOD205 Exp. 11/09/2021; AOD210 Exp. 11/18/2021; AOD215 Exp. 12/15/2021; AOD220 Exp. 01/20/2022.

Product
Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Recalling firm
Innoveix Pharmaceuticals Inc
Quantity
1,316 vials
Distribution
Nationwide within the United States
Recall date
July 28, 2021
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls