Medications & Supplements/Prescription Drugs

Innoveix Pharmaceuticals Inc: Compounded Injectable Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: July 20, 2021

Summary

Innoveix Pharmaceuticals Inc is recalling 2,044 vials of compounded Semorelin/Ipamorelin and AOD-9604 injectable medications because they lack assurance of sterility. These prescription drugs are intended for subcutaneous or intramuscular injection, and if they are contaminated with bacteria or fungi, they can cause serious infections or other life-threatening complications. The affected products include 728 vials of Semorelin/Ipamorelin and 1,316 vials of AOD-9604 distributed nationwide to healthcare providers and patients.

Risk

Injecting a drug that is not sterile can introduce bacteria or fungi directly into the body's tissues or bloodstream, potentially causing severe infections at the injection site or systemic illness.

What You Should Do

Check your medication vials for Compounded Lyophilized Semorelin/Ipamorelin 3 mg with lot numbers SIP215 (Exp. 01/14/2022), SIP220 (Exp. 01/23/2022), or SIP210 (Exp. 12/15/2021).
Check your medication vials for Compounded Lyophilized AOD-9604 3 mg with lot numbers AOD205 (Exp. 11/09/2021), AOD210 (Exp. 11/18/2021), AOD215 (Exp. 12/15/2021), or AOD220 (Exp. 01/20/2022).
Immediately stop using any medications from these specific lot numbers.
Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse effects.
Return any unused product to the pharmacy or place of purchase for a refund and contact Innoveix Pharmaceuticals at 800-370-1910 for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and product return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Compounded Lyophilized Semorelin/Ipamorelin 3 mg

Lot Numbers:

SIP215 (Exp. 01/14/2022)

SIP220 (Exp. 01/23/2022)

SIP210 (Exp. 12/15/2021)

Date Ranges: Expiration dates: 12/15/2021, 01/14/2022, 01/23/2022

Product: Compounded Lyophilized AOD-9604, 3 mg

Lot Numbers:

AOD205 (Exp. 11/09/2021)

AOD210 (Exp. 11/18/2021)

AOD215 (Exp. 12/15/2021)

AOD220 (Exp. 01/20/2022)

Date Ranges: Expiration dates: 11/09/2021, 11/18/2021, 12/15/2021, 01/20/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88159

Status: Resolved

Manufacturer: Innoveix Pharmaceuticals Inc

Sold By: Innoveix Pharmaceuticals Inc

Manufactured In: United States

Units Affected: 2 products (728 vials; 1,316 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication vials for Compounded Lyophilized Semorelin/Ipamorelin 3 mg with lot numbers SIP215 (Exp. 01/14/2022), SIP220 (Exp. 01/23/2022), or SIP210 (Exp. 12/15/2021).

Check your medication vials for Compounded Lyophilized AOD-9604 3 mg with lot numbers AOD205 (Exp. 11/09/2021), AOD210 (Exp. 11/18/2021), AOD215 (Exp. 12/15/2021), or AOD220 (Exp. 01/20/2022).

Immediately stop using any medications from these specific lot numbers.

Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse effects.

Return any unused product to the pharmacy or place of purchase for a refund and contact Innoveix Pharmaceuticals at 800-370-1910 for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Compounded Lyophilized Semorelin/Ipamorelin 3 mg

Lot Numbers:

SIP215 (Exp. 01/14/2022)

SIP220 (Exp. 01/23/2022)

SIP210 (Exp. 12/15/2021)

Date Ranges: Expiration dates: 12/15/2021, 01/14/2022, 01/23/2022

Product: Compounded Lyophilized AOD-9604, 3 mg

Lot Numbers:

AOD205 (Exp. 11/09/2021)

AOD210 (Exp. 11/18/2021)

AOD215 (Exp. 12/15/2021)

AOD220 (Exp. 01/20/2022)

Date Ranges: Expiration dates: 11/09/2021, 11/18/2021, 12/15/2021, 01/20/2022