Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.
Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of assurance of sterility.
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