Medications & Supplements/Prescription Drugs

Revive Rx Tirzepatide Sterile Solution Recalled for Sub-potency

Agency Publication Date: May 25, 2023

Summary

Revive Rx LLC is recalling 45 vials of compounded Tirzepatide 10 mg/0.5 mL Sterile Solution because the medication is sub-potent, meaning it contains less than the intended amount of the active drug. This compounded product is an injectable medication provided in 2 mL vials. Consumers who use this medication should consult with their healthcare provider or pharmacist about the effectiveness of their treatment.

Risk

A sub-potent drug may not provide the full therapeutic benefit intended by the prescriber, potentially leading to a lack of effectiveness in managing the patient's condition.

What You Should Do

This recall affects Tirzepatide 10 mg/0.5 mL Sterile Solution sold in 2 mL vials under the Revive Rx brand, identified by NDC 99000-9278-64.
Check your vial for lot number 1643397 with a beyond-use date (BUD) of 10/16/2023.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Revive Rx LLC directly at 3831 Golf Dr A, Houston, TX 77018 for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vialby Revive Rx

Variants: 10 mg/0.5 mL, 2 mL Vial, Sterile Solution, Compounded

Lot Numbers:

1643397 (BUD: 10/16/2023)

NDC:

99000-9278-64

Compounded Drug Product By: Revive Rx

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92329

Status: Active

Manufacturer: Revive Rx LLC dba Revive Rx Pharmacy

Sold By: Revive Rx Pharmacy

Manufactured In: United States

Units Affected: 45 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

This recall affects Tirzepatide 10 mg/0.5 mL Sterile Solution sold in 2 mL vials under the Revive Rx brand, identified by NDC 99000-9278-64.

Check your vial for lot number 1643397 with a beyond-use date (BUD) of 10/16/2023.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Revive Rx LLC directly at 3831 Golf Dr A, Houston, TX 77018 for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.