Optimal Balance Pharmacy has issued a nationwide recall for certain lots of its Compounded Glutathione 200 mg/mL Multi-Dose Vials due to identified elevated bacterial endotoxin levels, posing a risk of serious medical events.
The pharmacy's testing revealed the elevated endotoxin levels, which could lead to significant health issues such as fevers, hypotension, inflammatory reactions, anaphylactic shock, and even death. Optimal Balance Pharmacy has already received reports of adverse events, including fever, chills, severe headache, nausea, vomiting, pain, and symptoms consistent with an allergic reaction.
The recalled compounded glutathione was distributed to consumers across 14 states: Arizona, Colorado, Florida, Illinois, Louisiana, Michigan, New York, Nevada, Oklahoma, Pennsylvania, Texas, Utah, Vermont, and Washington. Patients are advised to immediately stop using the product, quarantine any affected vials, and contact Optimal Balance Pharmacy for retrieval and a full refund.
Individuals who have used the recalled product and experienced any related symptoms should contact their prescribing physician. Health care professionals and patients are also encouraged to report any adverse events to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.