Optimal Balance Pharmacy: Glutathione 200 Mg/ml
Recall Summary Optimal Balance Pharmacy is recalling certain lots of compounded Glutathione 200 mg/mL multi-dose vials because they contain elevated levels of bacterial endotoxin. The recall affects patients who received this injectable medication from the pharmacy. Elevated endotoxin levels can cause adverse reactions when injected.
- Recalling firm
- OPTIMAL BALANCE PHARMACY
- 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
- Reason
- Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-05
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- USA Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/708e105e-bf1c-470e-bac3-5aba30a4961e