Class I recall: OPTIMAL BALANCE PHARMACY: Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutath

FDA reports a Class I recall of Optimal Balance Pharmacy's Glutathione 200 mg/mL sterile multidose injection vials, compounded for IM or IV use, after out-of-specification results were obtained for bacterial endotoxin, indicating microbial contamination of the sterile product. Class I recalls denote a reasonable probability that use of the product could cause serious adverse health consequences or death, as classified by FDA.

Most relevant for: Clinicians and patients using compounded injectable glutathione products from this pharmacy for IM or IV administration.

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