Optimal Balance Pharmacy recalls one lot of compounded glutathione injection over high endotoxin levels
Optimal Balance Pharmacy announced a voluntary recall of a single lot of its compounded glutathione 200 mg/mL multi‑dose vials. The recall was triggered after internal testing detected elevated bacterial endotoxin levels in the product.
The pharmacy warned that injectable products with high endotoxin levels can cause serious medical reactions, including fever, hypotension, inflammatory responses, anaphylactic shock and, in severe cases, death. To date, the company has received reports of adverse events such as fever, chills, severe headache, nausea, vomiting, pain and symptoms consistent with allergic reactions.
The affected glutathione vials, identified by lot number LG342009076, were distributed to patients in several states, including Arizona, Colorado, Florida and Illinois. The recall is being conducted at the patient level, and patients who received the product are advised to contact the pharmacy for further instructions.
Optimal Balance Pharmacy is working with the FDA to ensure the recall is completed promptly and to prevent any further exposure to the contaminated product.
This writeup was produced by pharmadog from original reporting by fda recalls.
Original headline: “Optimal Balance Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels”
read at fda recalls ↗
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