Recalls / Class II
Class IID-1319-2014
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
- Affected lot / code info
- Lot #: 130616, Exp 06/16
Why it was recalled
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
Recalling firm
- Firm
- Flawless Beauty LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1215 Main St, Asbury Park, New Jersey 07712-5940
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-04-29
- FDA classified
- 2014-05-13
- Posted by FDA
- 2014-05-21
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1319-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.