Class I · High risk Ongoing
Glutathione
Reason Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Tatiomax
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
What was recalled
Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576
- Recalling firm
- Flawless Beauty LLC
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1317-2014
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.
Other Glutathione recalls
See all
Class II · Moderate risk Ongoing
Glutathione Preserved for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Glutathione Magnesium for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glutathione L Reduced 100mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Completed
Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL…
Reason Lack of assurance of sterility.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.