Class I · High risk
Glutathione 200 mg/mL
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Glutathione injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Drug: Glutathione
- Recalling firm
- Auro Pharmacies, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1159-2018 · 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 recalls by Auro Pharmacies, Inc.
All 2018 recalls
Class III · Low risk
Biotin 10 mg/mL Injection
Failed pH Specification: product does not meet pH label claim.
Class II · Moderate risk
Methyl-Cobalamin injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Folic Acid injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Testosterone Enanthate/Cypionate injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
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