Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addi
Summary
The FDA issued a Class II for Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injectio by Innoveix Pharmaceuticals Inc. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0693-2021
Action Date
2021-07-28
Status
Completed
Category
drug
Product Description
Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Lot/Code Info: Lot #: AOD205 Exp. 11/09/2021; AOD210 Exp. 11/18/2021; AOD215 Exp. 12/15/2021; AOD220 Exp. 01/20/2022.
Quantity Affected: 1,316 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-09
Company
Addison, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 49 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Innoveix Pharmaceuticals Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Innoveix Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Innoveix Pharmaceuticals Inc have FDA actions?
Innoveix Pharmaceuticals Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0693-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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