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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 130616, Exp 06/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1319-2014
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Apr 29, 2014
- FDA report date
- May 21, 2014
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Flawless Beauty LLC
Original FDA data
Every field from FDA enforcement report D-1319-2014, exactly as published.
Show all FDA fields
- City
- Asbury Park
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 68158
- Address
- 1215 Main St
- Code information
- Lot #: 130616, Exp 06/16
- Postal code
- 07712-5940
- Report date
- May 21, 2014
- Product type
- Drugs
- Recall number
- D-1319-2014
- Classification
- Class II
- Recalling firm
- Flawless Beauty LLC
- Product quantity
- unknown
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 29, 2014
- Initial firm notification
- Press Release
- Center classification date
- May 13, 2014