D-009-2013 Class II Terminated
FDA drug recall D-009-2013 was initiated by Earthborn Products, Inc. on October 5, 2012 and is designated Class II. 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… The recall status is terminated (terminated February 28, 2013). Affected quantity: 161 gallons.
Recall Details
- Product Type
- Drugs
- Report Date
- October 24, 2012
- Initiation Date
- October 5, 2012
- Termination Date
- February 28, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 161 gallons
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.
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 009-22-A011, 011-28-A011, 004-01-A012, 005-24-A012, 007-24-A012, and 008-08-A012.