Drug product
Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count 5 mL vitamin C (ascorbic acid) solution diluent ampoules, and 30-count Advanced Glutathione Boosters capsules per box, Relumins Labs, 183 Locust Avenue, West Long Branch, NJ 07764, UPC 700175760302
D-1319-2014
Product summary
- Event
- Event 68158
- Status
- Completed
- Classification
- Class II
- Quantity
- unknown
- Official record key
drug-enforcement:D-1319-2014
Official wording
Reason: Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
Code information: Lot #: 130616, Exp 06/16
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.