Medications & Supplements/Prescription Drugs

RXQ Compounding LLC: Methylprednisolone Acetate Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: October 19, 2017

Summary

RXQ Compounding LLC is recalling 945 vials of methylprednisolone acetate (40 mg/mL) injection suspension because the equipment used to sterilize the medication may not have been operating correctly. This drug is a steroid used to treat various inflammatory conditions. Using a product that is not properly sterilized can lead to serious, life-threatening infections, particularly since this medication is administered by injection. The affected 10 mL vials were distributed to healthcare facilities in Florida, Louisiana, Massachusetts, Ohio, Pennsylvania, and Texas.

Risk

The failure to properly calibrate sterilization equipment (the autoclave) means the product may contain harmful bacteria or other microorganisms. Injecting a non-sterile drug directly into the body bypasses natural defenses and can cause severe localized or systemic infections.

What You Should Do

Check your medical supplies for methylprednisolone acetate 40 mg/mL injection suspension in 10 mL vials with NDC number 70731-0936-10.
Verify the specific lot information: Look for lot number 04252017@1 or 04252017 with an expiration date of 5/9/2018.
Immediately stop using the affected medication and quarantine any remaining vials to ensure they are not administered to patients.
Contact your healthcare provider or pharmacist if you have concerns about a past injection or if you are experiencing any signs of infection (such as redness, swelling, or fever at the injection site).
Return any unused vials of the recalled product to the pharmacy or place of purchase for a refund and contact RXQ Compounding LLC for further return instructions.
For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Drug recall refund and consultation

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

Affected Products

Product: methylPREDNIsolone ACETATE (40 MG/ML), 10 ML Vial

Model:

NDC: 70731-0936-10

Recall #: D-0012-2018

Lot Numbers:

04252017@1 (Exp 5/9/2018)

04252017

Date Ranges: Exp 5/9/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78175

Status: Resolved

Manufacturer: RXQ Compounding LLC

Sold By: Healthcare facilities; Hospitals; Clinics

Manufactured In: United States

Units Affected: 945 vials

Distributed To: Texas, Louisiana, Pennsylvania, Massachusetts, Florida, Ohio

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 medical supplies for methylprednisolone acetate 40 mg/mL injection suspension in 10 mL vials with NDC number 70731-0936-10.

Verify the specific lot information: Look for lot number 04252017@1 or 04252017 with an expiration date of 5/9/2018.

Immediately stop using the affected medication and quarantine any remaining vials to ensure they are not administered to patients.

Contact your healthcare provider or pharmacist if you have concerns about a past injection or if you are experiencing any signs of infection (such as redness, swelling, or fever at the injection site).

Return any unused vials of the recalled product to the pharmacy or place of purchase for a refund and contact RXQ Compounding LLC for further return instructions.

For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).