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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

ProRx Semaglutide and Tirzepatide Recalled for Sterility Concerns

Agency Publication Date: September 5, 2024
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Summary

ProRx LLC has recalled 16,604 vials of compounded injectable medications, including Semaglutide (often used for weight loss or diabetes) and Tirzepatide, because they may not be sterile. The recall involves various doses and sizes, including versions combined with Vitamin B12 (Cyanocobalamin). Using a non-sterile injectable drug can lead to serious or life-threatening infections. Consumers who have used these medications and have concerns should contact their doctor or pharmacist immediately.

Risk

A lack of assurance of sterility means the products could be contaminated with microorganisms such as bacteria or fungi. Injecting a contaminated product directly into the body can cause severe infections at the injection site or throughout the bloodstream.

What You Should Do

  1. This recall affects compounded Semaglutide and Tirzepatide injection products sold in multidose glass vials labeled as being manufactured by ProRx Exton, PA.
  2. Check the vial label for the product name, NDC codes (84139-225-01, 84139-210-01, 84139-225-04, 84139-225-02, or 84139-210-02), and the lot number or Beyond Use Date (BUD). See the Affected Products section below for the full list of affected codes.
  3. 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 ProRx LLC at 267-565-7008 for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: Semaglutide Compounded RX Product (2 mL)
Variants: 2.5mg/mL, Multidose SC Injection, Glass vial
Lot Numbers:
ProRx031924 (BUD 09/18/2024)
ProRx032624 (BUD 09/25/2024)
ProRx041324 (BUD 10/12/2024)
NDC:
84139-225-01

Recall #: D-0650-2024; Quantity: 2,490 vials

Product: Tirzepatide Compounded Rx Product (2 mL)
Variants: 10 mg/mL, 20 mg/mL, Multidose SC Injection vials
Lot Numbers:
ProRx040924-1 (BUD 10/08/2024)
NDC:
84139-210-01

Recall #: D-0651-2024; Quantity: 37 vials

Product: SEMAGLUTIDE Compounded Drug (5mg/2mL)
Variants: 2.5mg/mL, Rx Only, Multiple Dose Vial
Lot Numbers:
ProRx052424 (BUD 11/23/2024)
ProRx060724 (BUD 12/06/2024)
ProRx061124 (BUD 12/10/2024)
ProRx061924 (BUD 12/18/2024)
NDC:
84139-225-01

Recall #: D-0652-2024; Quantity: 8,396 vials

Product: SEMAGLUTIDE Compounded Drug (10mg/4mL)
Variants: 2.5mg/mL, Rx Only, Multiple Dose Vial
Lot Numbers:
ProRx061424 (BUD 12/13/2024)
NDC:
84139-225-04

Recall #: D-0653-2024; Quantity: 1,960 vials

Product: Semaglutide / Cyanocobalamin Injection Compounded Rx Product (2 mL)
Variants: 2.5/0.5 mg/mL, Multiple Dose Vial
Lot Numbers:
ProRx031924-1 (BUD 09/18/2024)
NDC:
84139-225-02

Recall #: D-0654-2024; Quantity: 500 vials

Product: TIRZEPATIDE (20 mg/2mL)
Variants: 10 mg/mL, Rx Only, Multiple Dose Vial
Lot Numbers:
ProRx051424 (BUD 11/13/2024)
NDC:
84139-210-01

Recall #: D-0655-2024; Quantity: 1,489 vials

Product: TIRZEPATIDE (60 mg/3mL)
Variants: 20 mg/mL, Rx Only, Multiple Dose Vial
Lot Numbers:
ProRx052224 (BUD 11/21/2024)
ProRx061024 (BUD 12/09/2024)
NDC:
84139-210-02

Recall #: D-0656-2024; Quantity: 1,732 vials

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95190
Status: Active
Manufacturer: ProRx LLC
Sold By: ProRx LLC
Manufactured In: United States
Units Affected: 7 products (2,490 vials; 37 vials; 8,396 vials; 1,960 vials; 500 vials; 1,489 vials; 1,732 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 ยท 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.