Victory Medical Center Pharmacy — Class I: Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Ac
Victory Medical Center Pharmacy has initiated a Class I recall for Glutathione (MDV) 200 mg/mL in 30 mL vials due to out-of-specification results for bacterial endotoxin. The recall is currently classified as ongoing and involves sterile products intended for injection.
This recall affects Victory Medical Center Pharmacy, clinical staff utilizing their sterile glutathione multi-dose vials, and patients who may have been administered the contaminated product.
A Class I designation indicates the FDA's assessment of a reasonable probability that exposure will cause serious adverse health consequences or death. The presence of bacterial endotoxins in a sterile injectable indicates a significant failure in sterility assurance or raw material qualification, which likely signals broader systemic issues within the compounding facility's quality management system.
Immediate quarantine and reconciliation of affected MDV lots is necessary. QA teams should evaluate the effectiveness of sterile filtration and endotoxin testing protocols for multi-dose vials. Compliance departments should monitor for potential FDA follow-up regarding the facility's sterile manufacturing environment.
Class I. Reason: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.. Product: Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.. Firm: Victory Medical Center Pharmacy (Austin TX United States). Status: Ongoing.
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