FDA Recall Notice: VMC Compounded Glutathione Vials Contaminated With Endotoxin
Health Alert: Victory Medical Center Pharmacy (VMC) has voluntarily recalled multiple lots of its VMC Compounded Glutathione 200 mg/mL multi-dose vials after internal testing revealed bacterial endotoxin levels above the U.S. Pharmacopeia (USP) safety limit. Patients and providers in Texas, Florida, and New York should quarantine the product immediately and contact the pharmacy for instructions on returns and refunds.
Why VMC Compounded Glutathione Vials Were Recalled
Endotoxins are toxic components of certain bacterial cell walls. When injected, even trace amounts can provoke systemic inflammatory responses. VMC’s routine quality checks detected unacceptable endotoxin concentrations in the affected glutathione lots, prompting the recall to prevent potential reactions such as:
- Fever, chills, and body aches
- Severe headache, nausea, or vomiting
- Rapid heart rate or blood-pressure changes
- Injection-site pain or swelling
- Anaphylaxis or, in rare cases, death
VMC Compounded Glutathione Recall Lot Numbers
Compare the lot number on your vial or pharmacy invoice with the table below:
| Product | Lot Number | Expiration Date |
|---|---|---|
| VMC Compounded Glutathione 200 mg/mL (multi-dose) | 1980571 | Aug 27 2026 |
| VMC Compounded Glutathione 200 mg/mL (multi-dose) | 1981940 | Not listed |
| VMC Compounded Glutathione 200 mg/mL (multi-dose) | 1984345 | Not listed |
Sources
States Impacted by the Recall
Shipments of the recalled vials were distributed to patients and healthcare professionals in:
- Texas
- Florida
- New York
Immediate Actions for Patients and Prescribers
- Cease Use: Do not administer any glutathione from the affected lots.
- Quarantine Product: Store vials separately to avoid accidental use.
- Arrange Return & Refund: Call VMC at (512) 279-0985 to coordinate pickup and reimbursement.
- Monitor Health: Seek medical attention if you experience any of the symptoms listed above.
- Report Adverse Events: Submit a report to FDA MedWatch online or via mail/fax.
Official Images of the Recalled Vials
Frequently Asked Questions
Which VMC Compounded Glutathione lot numbers are included in the recall?
Lots 1980571, 1981940, and 1984345 of VMC Compounded Glutathione 200 mg/mL vials are affected.
Why is VMC Compounded Glutathione being recalled?
Testing detected elevated bacterial endotoxin levels, which can trigger serious inflammatory reactions when injected.
What health risks are associated with the recalled VMC Compounded Glutathione vials?
Risks include fever, chills, severe headache, nausea, rapid heart rate, changes in blood pressure, injection-site pain, and, in rare cases, anaphylactic shock.
How do I return my VMC Compounded Glutathione vials and obtain a refund?
Contact Victory Medical Center Pharmacy at (512) 279-0985 to schedule product retrieval and receive a full refund.
Can I keep using other VMC Compounded Glutathione lots not listed in the recall?
Only the specified lot numbers are affected. However, consult your pharmacist or prescriber before using any compounded medication if you have concerns.
How should healthcare professionals dispose of recalled VMC Compounded Glutathione vials?
Follow local regulations for pharmaceutical waste or return the product to VMC for proper disposal.
Where can I report side effects linked to VMC Compounded Glutathione?
File a report with FDA MedWatch online at fda.gov/MedWatch or submit the downloadable form via mail or fax.