Status
Terminated
Drug Enforcement D-009-2013
Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.
Classification
Class II
Report Date
October 24, 2012
Termination Date
February 28, 2013
Product Information
- Product description
- Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), d) 32 fl.oz (946.4 mL), e) 64 fl.oz (1.89 L), and f) 1 Gal. (3.78 L), Distributed by: Earthborn Products, San Diego, CA 92103.
- Product quantity
- 161 gallons
- Reason for recall
- Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Earthborn Products, Inc.
- Address
-
9275 Sky Park Ct Ste 101, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-009-2013
- Event ID
- 63406
- Recall initiation date
- October 5, 2012
- Center classification date
- October 18, 2012
- Code info
- Lot #: 009-22-A011, 011-28-A011, 004-01-A012, 005-24-A012, 007-24-A012, and 008-08-A012.
- More code info
- —