Class I · High risk
Glutathione 200 mg/mL
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Glutathione 100 mg/mL Injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
Drug: Glutathione
- Recalling firm
- Creative Compounds
- Origin
- OR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1019-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Glutathione recalls
See all
Class I · High risk
Glutathione
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class II · Moderate risk
Glutathione Preserved for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione Magnesium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione L Reduced 100mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Other microbial contamination recalls from 2013
All microbial contamination recalls
Class II · Moderate risk
Mangiacotti - Ginger Lime Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Pomegranate Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Clementine Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Ocean Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
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