Optimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
Optimal Balance Pharmacy is recalling 53 vials of Glutathione 200 mg/mL due to bacterial endotoxin contamination.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Optimal Balance Pharmacy is recalling 53 vials of Glutathione 200 mg/mL, 30 mL sterile multidose vials. The product is a prescription-only medication intended for intramuscular or intravenous injection. The recall was initiated because out-of-specification results were obtained for bacterial endotoxin, indicating microbial contamination of the sterile product.
The affected product is identified by Lot Number LG342009076 and has a Beyond Use Date of 10/4/26. The recall covers distribution across the USA nationwide.
Consumers and healthcare providers should stop using the affected vials immediately. Patients should contact their healthcare provider for guidance on alternative treatments or further medical evaluation if they have already used the product.
The recalled product
- Product
- Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090
- Manufacturer
- OPTIMAL BALANCE PHARMACY
- Affected units
- 53
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: LG342009076
- Beyond Use Date: 10/4/26
Distribution
Distributed nationwide across the United States.
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