D-0851-2026 Class I Ongoing
FDA drug recall D-0851-2026 was initiated by OPTIMAL BALANCE PHARMACY on August 5, 2026 and is designated Class I. Reason for recall: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. The recall status is ongoing. Affected quantity: 53 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 9, 2026
- Initiation Date
- August 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53 vials
Product Description
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
Reason for Recall
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Distribution Pattern
USA Nationwide.
Code Information
Lot#: LG342009076, Beyond Use Date: 10/4/26